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610

Dietitian-coached management in combination


with annual endocrinologist follow up improves
global metabolic and cardiovascular health in
diabetic participants after 24 months
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Marie-Claude Battista, Mélissa Labonté, Julie Ménard, Farrah Jean-Denis,


Ghislaine Houde, Jean-Luc Ardilouze, and Patrice Perron

Abstract: This 24 month study evaluated the effect of dietitian coaching combined with minimal endocrinologist follow up
on the glycemic control and cardiovascular risks of diabetic participants, compared with conventional endocrinologist follow
up. Participants with type 1 or type 2 diabetes were assigned to either the control group with conventional endocrinologist
follow up (C; n = 50) or the dietitian-coached group (DC; n = 51) with on-site diabetes self-management education every
3 months combined with annual endocrinologist followup. Over the 24 month intervention, weight (–0.7 vs. +2.1 kg; p =
0.04), BMI (+0.3 vs. +0.7 kg/m2; p = 0.009), and waist circumference (–1.3 vs. +2.4 cm; p = 0.01) significantly differed
between the DC and control groups. HbA1C dropped significantly in participants of the DC versus the control group (–0.6%
vs.–0.3%; p = 0.04). This was accompanied by improved overall energy intake (–548 vs. –74 kcal/day; p = 0.04). However,
no link associated glycemic control to nutrient intake or intensiveness of pharmacotherapy. Coaching by a dietitian improves
glycemic control and reduces certain cardiovascular risk factors in diabetic subjects, demonstrating that a joint dietitian–
endocrinologist model of care provides a convenient strategy for cardiovascular risk management in the diabetic population.
For personal use only.

Key words: dietitian, educator, diabetes, metabolic control, glycemic control, cardiovascular outcomes.
Résumé : Cette étude d’une durée de 24 mois évalue, comparativement au suivi traditionnel d’un endocrinologue, l’effet
de la supervision d’une diététiste combinée à un suivi minimal de l’endocrinologue sur le contrôle glycémique et les risques
cardiovasculaires chez des diabétiques. Les participants présentant un diabète de type 1 ou 2 sont assignés soit au groupe de
contrôle incluant le suivi traditionnel de l’endocrinologue (C; n = 50), soit au groupe expérimental incluant le suivi du dié-
tétiste (DC; n = 51) et comprenant sur place un enseignement de l’autocontrôle tous les trois mois combiné au suivi annuel
de la part de l’endocrinologue. Après 24 mois de suivi, la masse corporelle (–0,7 vs. +2,1 kg; p = 0,04), l’IMC (+0,3
vs. +0,7 kg/m2; p = 0,009) et le tour de taille (–1,3 vs. +2,4 cm; p = 0,01) diffèrent significativement entre les groupes DC
et C respectivement. La valeur de HbA1C a diminué significativement dansle groupe DC comparativement au groupe C :
(–0,6 % vs. –0,3 %; p = 0,04). Dans l’ensemble l’apport d’énergie est plus faible : (–548 kcal vs. –74 kcal/jour; p = 0,04).
Cependant, on n’observe aucune relation entre le contrôle de la glycémie et l’apport nutritionnel ou l’ampleur de la pharma-
cothérapie. La supervision par un diététiste améliore le contrôle de la glycémie et diminue le risque de troubles cardiovascu-
laires chez des diabétiques; le modèle combinant le suivi du diététiste et de l’endocrinologue constitue donc une stratégie
efficace pour la gestion des risques cardiovasculaires dans la population des diabètes.
Mots‐clés : diététiste, formateur, diabète, contrôle métabolique, contrôle glycémique, conséquences cardiovasculaires.
[Traduit par la Rédaction]

Introduction over 300 million individuals by 2025 (WHO 2001). In 2009,


the Canadian Diabetes Association (CDA) anticipated that
The incidence of diabetes mellitus is increasing at an approximately 3 million Canadians will have developed dia-
alarming rate. According to the World Health Organization betes in 2011 (CDA 2009). This growing epidemic threatens
(WHO), the number of individuals with type 2 diabetes to overwhelm healthcare services worldwide, especially given
(T2D) will double over the next 25 years and will affect its exacerbating effect on associated burdens, which include

Received 7 September 2011. Accepted 19 January 2012. Published at www.nrcresearchpress.com/apnm on 25 April 2012.
M.-C. Battista,* M. Labonté,* J. Ménard, F. Jean-Denis, G. Houde, J.-L. Ardilouze†, and P. Perron.† Division of Endocrinology,
Department of Medicine, Faculté de Médecine et des Sciences de la Santé, Université de Sherbrooke, 3001, 12th Ave North, Sherbrooke,
QC J1H 5N4, Canada.
Corresponding author: Patrice Perron (e-mail: Patrice.Perron@USherbrooke.ca).
*First authors.
†Senior authors.

Appl. Physiol. Nutr. Metab. 37: 610–620 (2012) doi:10.1139/H2012-025 Published by NRC Research Press
Battista et al. 611

cardiovascular risk factors and diseases (Coutinho et al. included in the study if they had a diagnosis of T2D and a
1999). HbA1c ≥ 7.0% (CDA 2003) or a diagnosis of T1D and dis-
To curb this trend, intensive lifestyle interventions and pa- played at least one of the following cardiovascular risks:
tient education are fundamental and regarded as milestones in LDL-C ≥ 2.0 mmol/L; blood pressure (≥130/80) or taking blood
disease management. It is recognized that effective patient pressure medication; triglycerides >1.5 mmol/L; HDL-C <
education impacts positively on care, self-management, and 0.90 mmol/L; or a total cholesterol to HDL-C ratio >4.0.
adherence (Albano et al. 2008; Davies et al. 2008). Accord- Participants were excluded if they were pregnant, receiving
ingly, national recommendations suggest that the role of dia- corticosteroids, or had been seen more than three times by
betes educators should be enhanced in cooperation with the their endocrinologist for extra follow up care. Exclusion cri-
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treating physician to improve coordination of care and pro- teria were minimal in order to assess real world day-to-day
mote improvements in diabetes management (Blonde et al. clinical practice. The Research Ethics Institutional Review
2006; CDA 2008). Currently, even though multidisciplinary Board of the Étienne–Le Bel Clinical Research Centre at
diabetes care team studies that include physicians, nurses, the CHUS approved the research protocol. Upon determin-
pharmacists, and (or) dietitians, have demonstrated a range ing patient eligibility, the endocrinologist first provided an
of successful data regarding diabetes management; many explanation of the study and then referred the control group
methodological concerns have been raised with respect to to the research assistant and the DC group to the dietitian
small sample size, short intervention period, or study bias for informed consent. Consent was provided in writing prior
(Haskell et al. 2006; Trento et al. 2008; Ma et al. 2009; Far- to participation as required by all applicable laws and regu-
saei et al. 2011). lations.
Registered dietitians are highly skilled professionals, rec-
ognized as both quality care providers and educators for dia- Intervention program
betic patients (Franz 2007). It follows that dietitians have an When assigned to the control group, participants received
important role to play within multidisciplinary diabetes care conventional care and follow up; for example, they were
teams. Accordingly, the Diabetes Prevention Program pro- seen 1–3 times a year by an endocrinologist and also by a
vided clear indications for an integral role of the dietitian general practitioner. During these visits, CDA recommenda-
into lifestyle management to help patients change their eating tions regarding nutrition and physical activity were taught to
For personal use only.

and exercise behaviours and prevent diabetes complications the patients (CDA 2003, 2008). When needed, medication
(Wylie-Rosett and Delahanty 2002). was adjusted to meet CDA recommended glucose, lipid, and
Despite the variety of educational programs, including cardiovascular target values. In the DC group, in addition to
multidisciplinary team coaching, which have been developed the annual follow-up visit with the endocrinologist, partici-
for people with diabetes, few studies actually aimed to im- pants were seen every 3 months by the dietitian and also re-
prove the quality of such programs. One way to improve ex- ceived monthly phone calls between visits as a motivational,
isting programs might be through a minimal multidisciplinary educational, and therapy adjustment tool. Each 30 min visit
team composed of a single highly skilled educator/coach act- with the DC group participants consisted of (1) blood sam-
ing together with a physician. To our knowledge, the role of pling for biochemical tests; (2) anthropometric measure-
dietitian–educators combined with endocrinologist follow up ments; (3) non-smoking reinforcement and support as
of diabetes-related cardiovascular outcome has never been as- required; (4) review of self-monitoring glucose data — par-
sessed over long-term management and treatment of type 1 ticipants were asked to monitor their blood glucose twice
and type 2 diabetes in Canada. Here, we put forth a joint daily with a glucometer; (5) advice on physical activity; (6)
model of care combining registered dietitian coaching with counselling and education regarding nutrition and dietary
annual endocrinologist follow up, to better monitor and pro- plans; (7) pharmacotherapy adjustment upon consultation
mote global metabolic and cardiovascular health in diabetic with the endocrinologist; (8) complication management; and
patients. This study compared conventional care provided by above all (9) motivational support.
endocrinologists alone over a 24 month period with the pro-
posed dietitian–endocrinologist joint model. Physical activity recommendations
Participants of the DC group were provided with pedome-
Research design and methods ters (Yamax, SW-200, Ill., USA) and asked to exercise
60 min per day at moderate intensity (CDA 2003, 2008).
Participants Physical activity in both groups was also assessed using a
Participants were recruited through the Diabetes Clinic at standardized questionnaire (Pereira et al. 1997). Daily energy
the Centre Hospitalier Universitaire de Sherbrooke (CHUS) expenditure associated with reported activities was calculated
Fleurimont and Hôtel-Dieu sites, located 8 km apart. For lo- as metabolic equivalent task (MET) (Ménard et al. 2005).
gistical reasons, participants were referred to the dietitian-
coached (DC) group when seen at the Hôtel-Dieu site or re- Nutrition educational program
ferred to the control group when seen at the Fleurimont site. In the DC group, participants were supported in the devel-
However, all patients were evaluated by the same group of opment and maintenance of healthy nutritional behaviours ac-
endocrinologists according to the same guidelines. The only cording to the Canadian Nutrition Recommendations
difference between the two hospital sites was that the dieti- published by the CDA (2003, 2008) and Eating Well with
tian’s practice was based at the Hôtel-Dieu site. Participants Canada’s Food Guide (Health Canada 2007). The first goal
were recruited between April 2007 and April 2008, and was to introduce the concept of appropriate portion size and
were aged between 33 and 78 years. The participants were to emphasize the impact of carbohydrate count on glycemic

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612 Appl. Physiol. Nutr. Metab. Vol. 37, 2012

control. The second goal was to avoid excessive energy in- calculated from body weight and height measurements. Waist
take. A 3 day food record, including 2 weekdays and 1 week- circumference was measured with a flexible tape midway be-
end day, was given at baseline and every 6 months as a tween the last rib and the iliac crest, at the end of a normal
motivational tool to the DC group. This was reviewed by the expiration. Systolic (SBP) and diastolic blood pressure (DBP)
dietitian to evaluate dietary compliance and provide partici- were assessed using an electronic sphygmomanometer (VSM
pants with adequate individualized diet plans. Food record MedTech Devices Inc., Coquitlam, BC.). Blood samples
logbooks were also provided to control group participants were taken following a 12 h overnight fast. Plasma glucose
and returned to the research assistant but were not reviewed levels were measured using the glucose oxidase method. Se-
at baseline or at yearly visits. However, records were ana- rum was used to measure glycated hemoglobin (HbA1C) by
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lyzed by the dietitian for all participants of both groups using high-performance liquid chromatography (Bio-Rad VAR-
the NUTRIFIQ software for statistical analyses (version 2.5, IANT, Hercules, Calif.). Total cholesterol, HDL-C and trigly-
3rd revision, Québec, Canada, 2005). ceride concentrations were measured by a colorimetric
method (Johnson & Johnson Clinical Diagnostics, Rochester,
Pharmacotherapy adjustments NY). LDL-C was calculated using the Friedewald formula.
Pharmacotherapy as introduced, increased, or adjusted by Creatinine and microalbuminuria were, respectively, meas-
the endocrinologist was reported to the DC group partici- ured by colorimetric (CREAplus, Cobas) and immunoturbidi-
pants by the dietitian as required (at each 3 month visit) for metric (ALBT2, Cobas) assays.
those who had not reached CDA treatment goals with life-
style interventions. For control group participants, pharmaco- Statistical analysis
therapy was adjusted by an endocrinologist at routine visits
Statistical analyses were carried out according to the inten-
(1–3 times a year) and also by a general practionner.
tion-to-treat principle. Distribution of continuous variables
Briefly, optimal dosage and number of medications were
was assessed for normality and residual distribution was veri-
intensified according to therapeutic goals, secondary effects,
fied prior to performance of repeated-measures analysis of
and patient acceptance. Diabetes-treating agents used at a
covariance (ANCOVA). If not normally distributed, nonpara-
maximal daily dosage were the following: sulfonylurea
20 mg, meglitinide 16 mg, biguanide 2550 mg, and thiazoli- metrical analyses were performed and expressed as median
(25e – 75e percentiles). Otherwise, parametrical analysis were
For personal use only.

dinedione (rosiglitazone) 8 mg. Upon failure of the above to


yield HbA1c ≤ 7%, bedtime intermediate-acting insulin was conducted and expressed as mean ± SD or mean ± SEM.
added. Thereafter, insulin type, frequency of injections (1–4), Baseline characteristics and outcome variables at 24 months
and dosages were adjusted as needed. Lipid-lowering agents and baseline (d) were compared using independent student t
used at a maximal daily dosage consisted of the following: test, Mann–Whitney, or c2 tests. Intra-group analyses were
statins 80 mg to lower LDL-C, fibrates (fenofibrate) performed using the Wilcoxon test. Changes in proportion in
200 mg were prescribed for hypertriglyceridemia and low the same group were assessed with the McNemar test. Where
HDL-C. To maintain blood pressure level <130/80 mm applicable, Pearson or Spearman correlations were performed
Hg, any one of the following drugs was added and in- between the most significant parameters as a d of 24 months
creased as recommended (CDA 2003, 2008) as initial ther- to baseline, for each group. Parameters that were analyzed
apy, in the following order: ACE inhibitor, long-acting longitudinally were tested with repeated measures ANCOVA
calcium channel antagonists, thiazide-like diuretic, cardiose- with baseline values as covariates where appropriate. Where
lective beta blocker, angiotensin II receptor antagonists, and applicable, linear regression analyses were conducted to cor-
alpha-blocker. Pharmacotherapy data for all participants was rect for baseline differences. All p values were computed for
computerized. Moreover, for facilitating comparisons and a two-tailed test set for an a level of 0.05. The analyses were
given that several types of hypoglycemic, anti-hypertensive, performed using the SPSS software version 15.0 (Chicago,
and lipid-lowering drugs could also be given to patients in Ill., USA).
the control group, each oral drug dosage was calculated as
a percentage of the maximum recommended dosage. Results
Refill compliance rate was also monitored over the phone
with the participant’s pharmacist every 3 months. While there According to our inclusion criteria, 101 patients were re-
is no such thing as a consensual standard of “good compli- cruited at baseline; 51 were included in the DC group and
ance” since the level of compliance required to achieve de- 50 in the control group. During the 24 month follow up,
sired effects varies according to pharmacotherapy and within four patients were excluded and three dropped out of the DC
participants, for the purposes of this study however, a cut-off group. In the control group, two participants dropped out,
point of 80% was used to classify participants as compliant three died — two from cancer complications and one from a
(above 80%) or non-adherent (below 80%). Albeit arbitrary, ruptured aneurysm — and one suffered from a stroke. Ac-
this cut-off point is commonly used in compliance studies cordingly, 44 patients completed the study in each group.
for fusing antihyperglycemic and antihypertensive drugs The majority of participants were T2D non-smoking women.
(Lau and Nau 2004; Van Wijk et al. 2004). At baseline, no significant group differences relative to age,
sex, smoking status, diabetes type, diabetes duration, or num-
Measurement of clinical and biochemical parameters ber of participants on insulinotherapy were observed (Ta-
For DC participants, clinical and anthropometrical meas- ble 1). However, at baseline, micro- and macrovascular
urements were recorded at each visit with the dietitian as op- complications were significantly more frequent in the DC
posed to only yearly for control group participants. BMI was group than in the control group. Accordingly, statistically dif-

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Battista et al.
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Table 1. Baseline characteristics and changes of clinical parameters in diabetic patients after receiving either a dietitian-coached (DC) intervention or conventional care.

Baseline Changes from baseline to 24 months


Dietitian-coached (DC) Control (C) group; (n Dietitian-coached Adjusted p
group(n = 44) = 44) p value (DC) group Control (C) group p value value
Baseline caracteristics
Age (yrs) 60±11 59±11 0.67 — — —
Sex M/F, n (%) 10 (23) / 33(77) 15 (34) / 30 (66) 0.35 — — —
Smokers, n (%) 7 (16) 7 (16) 0.77 — — —
Type 1/2 diabetes, n (%) 7 (16) / 37 (84) 8 (18) / 36 (82) 0.77 — — —
Diabetes duration (yrs) 15±8 16±10 0.66 — — —
Insulin therapy, n (%) 32 (73) 37 (84) 0.20 — — —
Microvascular complications, 36 (82) 27 (63) 0.04
For personal use only.

n (%)
Macrovascular complica- 18 (41) 9 (21) 0.04
tions, n (%)
Clinical measurements
Weight (kg) 92±19 89±16 0.41 –0.7±4.2 2.1±4.4 0.004 0.003
BMI (kg/m2) 32±6 31±5 0.29 –0.3±1.5 0.7±1.8 0.009 0.001
WC (cm) 110±16 106±13 0.22 –1.3±1.4 2.4±7.3 0.009 0.01
Sbp (mm Hg) 130±15 133±17 0.40 –8.6±14.5 –3.0±15.9 0.94
Dbp (mm Hg) 74±9 77±11 0.12 –5.3±7.8 –1.3±10.3 0.049 0.07
FG (mM) 8.6±3.0 8.5±3.2 0.93 –0.7±3.8 –1.0±4.4 0.66
HbA1c (%) 7.9 (7.3–8.4) 7.7 (7.3–8.4) 0.87 –0.6 (–1.2–0.0) –0.3 (–0.7–0.2) 0.04 0.009
TC (mM) 3.81±0.77 4.07±0.79 0.16 –0.3±0.6 –0.3±0.71 0.93
LDL-C (mM) 1.88±0.67 2.04±0.68 0.30 –0.2±0.6 –0.2±0.6 0.76
HDL-C (mM) 1.19 ± 0.35 1.27±0.36 0.30 0.0±0.2 –0.1±0.2 0.22
TG (mM) 1.47 (1.06 – 2.13) 1.37 (0.83–2.27) 0.37 –0.1 (–0.4–0.2) 0.1 (–0.4–0.3) 0.13
TC/HDL-C 3.24 ± 1.02 3.44±1.31 0.43 0.1±0.7 0.0±0.8 0.70
A/C (mg/L) 1.4 (0.6 – 7.9) 1.2 (0.5–4.7) 0.20 –0.6 (–3.4 – –0.1) –0.2 (–0.9–0.7) 0.08
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Note: Results are expressed as mean ± SD, n (%) or median (1st–3rd interquartile ranges). A t test, c2 or Mann–Whitney test was used to test group difference at baseline. Depending on data
distribution, student t test or Mann–Whitney test was used to determine clinical parameters modification between both groups after the 24 months intervention. p <0.05 was considered signifi-
cantly different. Last p value column refers to linear regression analysis adjusting for micro- and macrovascular differences observed at baseline between groups. The number of observations
varies between 37 and 44. A, albumin; A/C, urinary albumine/creatinine (microalbuminuria); BMI, body mass index; C, control; DC, dietitian-coached; Dbp, diastolic blood pressure; F, female;
FG, fasting glucose; HbA1c, glycated hemoglobin; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; M, male; N/A, not applicable; TG, triglycerides;
Sbp, systolic blood pressure; TC, total cholesterol; WC, waist circumference.

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614 Appl. Physiol. Nutr. Metab. Vol. 37, 2012

ferent biochemical parameters were corrected for these base- In the DC group, the intervention failed to result in any
line differences. improvement in the number of steps as measured by pedom-
eter per day (p = 0.737). Accordingly, no difference in daily
Effects of dietitian intervention on clinical parameters expenditure in leisure activities either within or between
Table 1 presents clinical and biochemical results as base- groups was observed.
line values and their variation at the final 24 month follow
up. In comparison with control group participants who Effects of dietitian intervention on pharmacotherapy
gained weight, participants of the DC group lost weight adjustments
(+2.1 vs. –0.7 kg, p = 0.004) and shortened their waist cir- Participant compliance with anti-hypertensive, anti-diabetes,
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cumference (+2.4 vs. –1.3 cm, p = 0.009) over time. Accord- or cholesterol lowering agents was excellent and ranged be-
ingly, change in BMI was significantly different between tween 96% and 100% for each group over the entire study
groups: +0.7 in control vs. +0.3 in DC group, p = 0.009. period (data not shown). Table 3 shows the percentage of
These parameters remained significantly different between the maximum daily dosage for each drug used. At
groups, even after correction for micro- and macrovascular 24 months, participants of the DC group received 50%
complications (weight p = 0.003, waist circumference p = more angiotensin-converting enzyme inhibitor compared to
0.01, BMI p = 0.001). At 24 months, no significant improve- baseline (p = 0.04). In the control group, at 24 months,
ment in fasting plasma glucose between the DC and control participants were taking an additional 49% (p = 0.04) and
participants regardless of baseline glucose was observed. 30% (p = 0.02) of their initial dosages of calcium-channel
However, we found a significant improvement in HbA1c re- antagonist and diuretic drugs, respectively. Table 4 shows
gardless of baseline differences in participants of the DC that the number of participants on pharmacotherapy did not
group as compared to control subjects (–0.6% vs. –0.3%, differ between groups and during the intervention. However,
p = 0.04; adjusted p for micro- and macrovascular compli- the number of anti-hypertensive drugs was increased in the
cations, p = 0.009). While diastolic blood pressure (DBP) DC group (p = 0.04) at 24 months in comparison to base-
seemed to drop differently between control group and DC line. At 24 months, insulin doses rose significantly by 18%
group participants over time (–1.3 vs. –5.3 mm Hg, p = in the DC group as compared to only 7% in the control
0.049), this difference was abolished after adjustment for group (Table 3), although the number itself of participants
For personal use only.

micro- and macrovascular complications (p = 0.07). taking insulin did not significantly increase (Table 4).
To confirm data presented in Table 1 that depicts steady-
state clinical data between groups at baseline and 24 months, Correlations
avoid time-fluctuation bias, and better assess the evolution of In the DC group, improvement in HbA1c was positively as-
our intervention, parameters that were statistically different sociated with fasting glucose (r = 0.52; p = 0.001). With re-
between 24 months and baseline were linearly analyzed. Re- spect to cardiovascular improvement, although no association
sults obtained from this longitudinal analysis showed that between reduction in DBP and increased number of anti-
weight (Fig. 1A), BMI (Fig. 1B), waist circumference hypertensive agents was observed, there was a positive cor-
(Fig. 1C), diastolic blood pressure (Fig. 1D), and HbA1c relation between delta 24 months to baseline DBP and
(Fig. 1E) were significantly different between groups over waist circumference in the DC group (r = 0.362; p =
the study course. After correction for complications, all pa- 0.02). Moreover, in the DC group, no correlation was ob-
rameters remained significant, and only a tendency toward served between changes in HbA1c and weight (r = 0.053;
group difference was observable in the case of DBP p = 0.747) or waist circumference (r = 0.165; p = 0.310).
(Fig. 1D).

Effects of dietitian intervention on lifestyle behaviors Discussion


Table 2 shows the analyses of the 3 day food records. At We compared a joint model of diabetes care management
baseline, participants of the DC group were consuming 34% combining a motivational intervention program given by a
more kcal per day (p = 0.005) than participants in the control registered dietitian and a minimal yearly endocrinologist fol-
group. In terms of energy intake, the intervention resulted in low up to regular endocrinologist follow up, over a 24 month
a net reduction of energy (–548 vs. –74 kcal/day; p = 0.001 period, with HbA1c and cardiovascular risk factors as primary
vs. p = 0.179), and saturated fat (–3% vs. –1%; p = 0.005 vs. results. We showed that the joint dietitian-coached model of
p = 0.179) intake over the 24 month period in the DC versus intervention was successful as HbA1c, weight, BMI, waist cir-
the control group. Monounsaturated fat intake was similarly cumference, and dietary intakes were significantly modified
and significantly decreased in both groups over time. Since between groups over the 24 month period. However, we were
participants of the DC group ingested fewer kcal per day unable to directly associate these improvements to any spe-
than the participants of the control group, the 24 month inter- cific intervention given by the dietitian, suggesting an overall
vention resulted in significantly lower absolute values (g/day) benefit of the program. Moreover, this is the first study, to our
of protein (–14 vs. +1 g/day; p = 0.012 vs. p = 0.234), car- knowledge, to be conducted by a team composed only of a di-
bohydrates (–25 vs. +4 g/day; p = 0.019 vs. 0.196), and total etitian and an endocrinologist over a 24 month period in Can-
lipid intake (–30 vs. –5 g/day; p = 0.002 vs. 0.679). Over the ada. Previously, a Taiwanese study evaluated the impact of
course of the study period, a significant difference between dietitian management, in a primary-care setting, on glycemic
groups was observed in terms of energy (kcal/day) (p = control over a 12 month period (Huang et al. 2010).
0.045) although a similar tendency was observed for carbo- Surprisingly, we observed that participants of the DC
hydrates (p = 0.059). group presented twice as many micro- and (or) macrovascular

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Battista et al. 615

Fig. 1. Evolution of cardiovascular risk factors and glycemic control parameters in the two study groups over the entire course of intervention.
(A) Weight (kg); (B) Body Mass Index (BMI; kg/m2); (C) Waist circumference (cm); (D) Diastolic blood pressure (mm Hg); (E) Hemoglobin
A1c concentrations (%). Dietitian-coached (DC) results are shown using the black dots and full line while control (C) results are represented
by open dots and dotted lines. Results are expressed as mean (dots) ± SEM (bars). Boxes, p: are representative of intergroup interaction as
determined by repeated measures ANCOVA using a linear model. Adjusted p: analyses are adjusted for micro- and macrovascular differences
observed between groups at baseline. Residues distribution was verified and normally distributed for each parameter. The number of observa-
tions varies between 38 and 44.
100 A 34 B 112 C
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Waist circumference (cm)


110
33
95

BMI (kg/m2)
Weight (kg)

108
32
106
90
31
104
p=0.002 p=0.009 p=0.009
adjusted p=0.001 adjusted p=0.001 adjusted p=0.01
85 30 102
0 12 24 0 12 24 0 12 24
Time (months) Time (months) Time (months)

85 D 8.5 E
Diastolic blood pressure
For personal use only.

80
8.0
HbA1c (%)
(mmHg)

75 p=0.049 p=0.03 DC group


adjusted p=0.07 adjusted p=0.01 Control group
7.5
70

65 7.0
0 12 24 0 12 24
Time (months) Time (months)

complications at baseline than did control group partici- associated complications is linear, suggesting that any reduc-
pants. Data were corrected for this confounding factor, and tion in HbA1c profoundly impacts complications and associ-
showed significant improvement in glycemic control for DC ated outcomes. Indeed, the UKPDS reported that for every
group participants, with levels similar to recently observed 1% drop in HbA1c, microvascular complications fall by
in a joint pharmacist–physician and dietitian–nurse follow- 30%–35% in obese T2D patients (UK Prospective Diabetes
up study (Haskell et al. 2006; Ma et al. 2009; Hammad et Study Group 1998).
al. 2011). In line with our aim to reduce cardiovascular risk factors
With regard to glycemic control, the drop in HbA1c (0.6%) in our participants, we observed that our intervention posi-
was similar to that reported in recent randomized controlled tively impacted on adiposity in the DC group versus the con-
trials. Using dietitian-coached diabetes management together trol group, as measured over the course of the intervention by
with GP care, Huang and colleagues showed a 0.7% drop in weight (–0.7 vs. +2.1 kg), BMI (+0.3 vs. +0.7 kg/m2) and
HbA1c over a 12 month period in poorly controlled diabetic waist circumference (–1.3 vs. +2.4 cm). Similar results were
participants (n = 75) compared to only 0.2% in control sub- reported for the LOADD study (Coppell et al. 2010). This ef-
jects (n = 79) (Huang et al. 2010). The LOADD study, per- fect on adiposity is an improvement over our previous study,
formed in participants who were hyperglycemic despite as although our intensive 18 month multidisciplinary inter-
optimized drug treatment, showed that individualized and in- vention did cut HbA1c in poorly controlled diabetic patients,
tensive nutritional intervention resulted in a 0.4% HbA1c dif- it did not curb weight gain (Ménard et al. 2005). Thus, the
ference between intervention (n = 45) and control (n = 48) weight loss (–0.7 kg) demonstrated in diabetic patients of
groups, over a 6 month period, without significant changes the DC group is of clinical importance. This result sharply
in plasma glucose levels (Coppell et al. 2010), as also ob- contrasts with results from the use of anti-diabetic drugs and
served in this study. Although the drop in HbA1c may seem insulin for which weight gain is, in fact, a common side ef-
modest (0.6%), the relationship between HbA1c and diabetes- fect (Leslie et al. 2007; Holman et al. 2009). The fact that

Published by NRC Research Press


616 Appl. Physiol. Nutr. Metab. Vol. 37, 2012

Table 2. Changes in nutrient intake and physical activity at baseline and 24 months after receiving either a dietitian-coached (DC) interven-
tion or conventional care.

Dietitian-coached group (n = 30) Control group (n = 16) p value d


between
Nutrient intake Baseline 24 months Baseline 24 months groups
Energy (kcal/day) 2362 (1812–2664)†† 1814 (1548–2300) 1768 (1568–2109) 1694 (1499–1962) 0.045
***
Protein
Appl. Physiol. Nutr. Metab. Downloaded from www.nrcresearchpress.com by George Mason University on 05/02/13

Energy (%) 17 (15–19) 18 (16–20) 16 (14–19) 18 (16–21) 0.368


g/day 95 (83–108) †† 81 (68–100) ** 76 (65–82) 77 (69–89) 0.014
Carbohydrates
Energy (%) 43 (38–48) 47 (41–53)* 46 (42–53) 47 (43–50) 0.059
g/day 238 (193–300) 213 (170–260) * 203 (169–273) 207 (176–230) 0.393
Fat
Energy (%) 40 (34–43) 36 (29–40) 37 (33–41) 36 (33–39) 0.189
g/day 94 (72–128) † 64 (55–104) ** 73 (67–88) 68 (60–84) 0.028
Saturated fat (%) 13 (11–15) 10 (9–13)** 13 (10–16) 12 (10–13) 0.580
Monounsaturated fat (%) 16 (13–17) 14 (11–15)* 17 (13–20) 13 (12–15)* 0.433
Polyunsaturated fat (%) 7 (6–9) 7 (5–8) 8 (6–9) 7 (5–9) 0.612
Fibers (g/day) 18 (14–24) 20 (16–24) 17 (15–23) 17 (13–21) 0.240
Physical activities
Steps/daya 4411 (2686–8711) 5155 (2380–7344) — — N/A
Daily expenditure in lei- 0.55 (0.04–1.59) 0.83 (0.01–2.49) 0.94 (0.00–1.67) 0.25 (0.00–1.41) 0.064
sure activitiesb (kcal/kg/
day)
Note: Results are expressed as median (1st–3rd interquartile ranges). The Mann–Whitney test was used for inter-group data analysis at baseline and at
For personal use only.

24 months; †p ≤ 0.05, ††p ≤ 0.01. The Wilcoxon’s signed-rank test was used for intra-group data analysis; *p ≤ 0.05, **p ≤ 0.01, ***p ≤ 0.001. The p value
in the last column refers to the delta difference (24 months – baseline) between groups using the Mann–Whitney test. MED (IQR) = median interquartile
range.
a
n = 20 in the DC group.
b
n = 42 and 44 in the DC and control group, respectively.

the majority (77%) of DC participants were on insulinoher- after correction for baseline differences. Data from the litera-
apy at 24 months — and that insulin doses at 24 months ture seem conflicting as to the effectiveness of intervention
were 18% above those at baseline — would seem to suggest on blood pressure and lipid control (Haskell et al. 2006;
that the joint dietitian-coached intervention actually overcame Huang et al. 2010; Coppell et al. 2010). Results suggest that
the obesogenic effects of medication. In line with this, is the our joint dietitian-coached intervention is no better than other
observation that intensification of anti-diabetic drug therapy interventions using combined and diverse medical specialists.
in the control group participants resulted in added adiposity One possible explanation for the intervention’s failure to im-
(weight: +2.1 kg; BMI: +0.7 kg/m2; waist circumfer- prove DBP or lipids may simply be due to the fact that base-
ence: +2.4 cm over the 24 month intervention period). While line values were already close to target levels and that
added adiposity was observed in the absence of increased antihypertensive and lipid medications are effective.
caloric intake, it is important to stress that nutritional data As our intervention was dietitian-based, we also questioned
were self-reported by participants. In fact, control group par- the benefit of promoting better lifestyle habits on cardiovas-
ticipants followed Canadian energy recommendations (i.e., cular and metabolic improvement. It is well known that, in
2150 kcal/day for men and 1750 kcal/day for women). Obe- the diabetic population, recommended dietary and physical
sity, and particularly abdominal adiposity, is a recognized and activity guidelines are seldom followed (Nelson et al. 2002).
independent cause of cardiometabolic risk (Gastaldelli and Our current joint dietitian-coached intervention resulted in
Basta 2010). Importantly, the Quebec Health Survey (Poirier greater reductions in energy intake — a 23% drop in energy
et al. 2005), which studied more than 1800 men and women, intake was observed in the DC group at 24 months — than
concluded that obesity, fasting insulin, insulin sensitivity, and were our previous study using a multitherapy program (11%
blood pressure were largely explained by variations in waist over 12 months — Ménard et al. 2005) and the dietitian-
circumference, one of the main parameters modified in our coached Taiwanese study (12% at 12 months — Huang et al.
study. Our joint dietitian-coached care management model 2010). Compared to Huang et al. (2010) our current nutri-
thus offers an interesting and innovative alternative strategy tional intervention also resulted in a greater drop in monoun-
to reduce diabetes-associated complications and cardiovascu- saturated (+12.5% in our study vs. +6.0%), saturated
lar diseases. (–23.1% vs. –11.3%), and absolute total fat (–31.9% vs.
With respect to blood pressure and lipid control, our study –11.9%) intake, although carbohydrate and protein intakes
intervention failed to provide any clear benefit over regular were similar in both studies. It was previously shown,
care. Even though DBP seemed to improved in DC partici- inT2D patients, that a reduction in saturated fat intake was
pants compared to controls, only a tendency was observable associated with improved glycemic control (Nelson et al.

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Battista et al.
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Table 3. Dosage of oral medications as a percentage of the maximum daily dosage at baseline and 24 months after receiving either a dietitian-coached (DC) intervention or
conventional care.

Dietitian-coached group Control group


Drugs n Baseline 24 months n Baseline 24 months
Glucose-lowering agents
Sulfonylurea 8 75 (31–100) 50 (31–50) 6 50 (23–81) 44 (31–63)
Meglitinide N/A N/A N/A 2 69 (47–56) 44 (9–56)
For personal use only.

Biguanide 28 78 (78–100) 78 (61–78) 24 88 (67–100) 78 (67–100)


Thiazolidinedione 9 100 (50–100) 50 (50–100) 12 100 (54–100) 100 (100–100)
Insulin dose (U/kg/day) 31 0.73 (0.49–1.13) 0.86 ** (0.50–1.40) 32 0.60 (0.34–0.95) 0.64 * (0.44–1.11)
Lipid-lowering agents
Statin 35 25 (25–50) 50 (25–50) 35 50 (25–50) 50 (25–50)
Fibrate N/A N/A N/A 3 80 (80–100) 80 (80–100)
Antihypertensive agents
Angiotensin-converting enzyme 18 50 (46–100) 75 (50–100)* 21 50 (38–94) 50 (50–100)
inhibitor
Calcium-channel antagonist 9 100 (58–100) 100 (58–100) 11 67 (50–100) 100 (83–100)*
Diuretic 19 10 (6–13) 13 (8–13) 23 10 (6–13) 13 (6–15)*
b-Blocker 13 50 (25–50) 25 (25–50) 9 25 (25–50) 38 (25–50)
Angiotensin-ІІ receptor antagonist 20 100 (50–100) 100 (50–100) 15 100 (100–100) 100 (50–100)
Alpha-1 blocker 3 20 (5–25) 20 (10–30) N/A N/A N/A
Note: Maximum daily dosages were chosen according to the 2007 and 2008 Compendium of Pharmaceuticals and Specialities. Results are expressed as median (1st–3rd interquartile ranges). The
Mann–Whitney test was used for inter-group data analysis. No differences were observed between groups at baseline. The Wilcoxon’s signed-rank test was used for intra-group data analysis; *p < 0.05.
N/A, not enough valid cases to proceed with analysis. For the same reason, no mention is made regarding beta-2 adrenergic agonist and incretin drugs.
Published by NRC Research Press

617
618 Appl. Physiol. Nutr. Metab. Vol. 37, 2012

Table 4. Outcome of pharmacological therapies in participants at baseline and 24 months after receiving either a dietitian-coached (DC)
intervention or conventional care.

Dietitian-coached group (DC) Control group


Drugs Baseline 24 months p value Baseline 24 months p value
Glucose-lowering agents
0 OHA 13 (30) 16 (36) 0.416 15 (34) 16 (36) 0.293
1 OHA 13 (30) 14 (31) 9 (20) 13 (30)
2 OHA 10 (23) 7 (16) 11 (25) 9 (20)
Appl. Physiol. Nutr. Metab. Downloaded from www.nrcresearchpress.com by George Mason University on 05/02/13

3 OHA 8 (18) 7 (16) 9 (20) 6 (14)


OHA alone 12 (27) 10 (23) 0.072 15 (34) 11 (25) 0.082
Insulin and OHA 13 (30) 15 (34) 10 (23) 11 (25)
Insulin alone 19 (43) 19 (43) 19 (43) 22 (43)
Lipid-lowering agents
0 agent 7 (16) 7 (16) 1.000 6 (14) 3 (7) 0.180
1 agent 33 (75) 33 (75) 30 (68) 33 (75)
2 agents 4 (9) 4 (9) 8 (18) 8 (18)
Antihypertensive agents
0 agent 6 (14) 5 (11) 0.040 3 (7) 4 (9) 0.502
1 agent 7 (16) 7 (16) 15 (34) 12 (27)
2 agents 17 (39) 12 (27) 7 (16) 9 (20)
3 agents 5 (11) 13 (30) 13 (30) 12 (27)
≥4 agents 9 (20) 7 (17) 6 (14) 7 (17)
Note: Results are expressed as the number and percentage of patients taking each category of medication. Insulin doses are expressed as median (1st–3rd
interquartile ranges). The Mann–Whitney test was used for inter-group insulin dose analysis at baseline. No differences were observed between groups at
baseline. The Wilcoxon’s signed-rank test was used to detect intra-group difference for insulin dose. p value column expresses McNemar test values for intra-
For personal use only.

group data analysis. OHA, oral hypoglycemic agents.

2002). In our current study, improvement in nutritional hab- motivation toward physical activity. Interestingly, a quantita-
its in the DC group did not correlate with the improvement tive bias was reported toward pedometers as obese partici-
of any clinical parameters. It is therefore unlikely that cardi- pants were less compliant than the non-obese (Renault et al.
ovascular risk factors and glycemic improvements seen in 2010) and that long-term individual motivation was a major
DC participants are directly attributable to better dietary issue associated with poor physical activity in this population
habits. Nutritional data were self-reported by participants (Harvey et al. 2009). A recent report demonstrated that it was
and while food records are an important tool, they confer easier for T2D patients to manage diet recommendations than
inherent limitations to our study design and analysis. Impor- to exercise (Oftedal et al. 2011). Taken together, these results
tantly, the control group's food logbooks were simply suggest that diabetic patients need to be actively supervised
handed over by the participants to the research assistant and motivated, on a frequent basis, rather than provided with
and were not reviewed with the participant. However, in passive tools when expected to improve their physical activ-
the DC group, food logbooks were immediately handed ity habits.
over to the dietitian and carefully reviewed with partici- It was previously thought that the successful intervention
pants. Thus, the dietitian immediately and actively started in improving glycemic control was based on rapid and sus-
promoting lower energy intake among DC participants by tained pharmacotherapy changes in diabetic patients (Mehuys
closely investigating and assessing their daily intakes and et al. 2010). In our current study, pharmacotherapy adjust-
asking additional questions. This may explain, at least in ment was part of overall management in both groups. Results
part, the difference in energy intake between groups at show that the number of prescribed glucose-lowering agents
baseline. Because of this bias and the fact that many partic- and their dosages was no different between groups. Insulin
ipants did not completed their logbooks, we chose not to doses however were increased at 24 months compared to
correct for biochemical data obtained with a greater number baseline, in both groups. In secondary analyses, we showed
of participants, with this nutritional variable. that administration of anti-diabetic drugs did not correlate
Physical activity is another important aspect to consider in with observed anthropometric or HbA1c measurements in the
any lifestyle management intervention. Because the current DC group participants. Moreover, we showed that the drop in
study used only questionnaires and pedometers as motiva- HbA1c was not correlated with the rise in insulin in the DC
tional tools, it did not result in any significant improvement participants. Furthermore, HbA1c was improved independ-
in physical activity. This contrasts with our previously pub- ently of insulin therapy (data not shown). Thus, our results
lished multidisciplinary approach in which a supervised exer- suggest that the improvement on HbA1c in the DC partici-
cise program, given to diabetic patients, resulted in improved pants was not exclusively attributable to medication adjust-
physical activity in the intervention group compared to the ment. Our results, however, apparently contradict those
conventional care group (Ménard et al. 2005). One limitation reported by Wolf et al. (2004) showing that improved HbA1c
of our current study is related to providing participants with was accompanied by a reduction in the number of diabetic
only a pedometer for a relative long period, 24 months, as medications and insulin use after 12 months of a registered

Published by NRC Research Press


Battista et al. 619

dietitian intervention in the case management group (Wolf et wrote the manuscript. M.L. contributed to data acquisition,
al. 2004). Our results, even after a 24 month intervention, data interpretation and analysis. J.M. was involved in study
were also contrary to the reported speculation by Wolf et al. design. F.J.-D. contributed to data acquisition. G.H. contrib-
(2004) that, after the 12 month intervention, a drop in HbA1c uted to study design and data acquisition. J.-L.A. and P.P.
may precede the reduction in pharmacotherapy use (Wolf et both participated in the study concept and design. P.P. also
al. 2004). Nonetheless, our data do support the conclusion participated in supervision, data acquisition, analyses, and
that motivational care and management provided by a dieti- data interpretation. All of the authors critically revised the
tian is successful in improving metabolic and cardiovascular manuscript for important intellectual content and gave final
risk factors independently of adjustments in medications. Ac- approval for the article to be published.
Appl. Physiol. Nutr. Metab. Downloaded from www.nrcresearchpress.com by George Mason University on 05/02/13

cordingly, the Diabetes Prevention Program study, performed


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