Professional Documents
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Diabetes Care
Diabetes Care
O R I G I N A L
A R T I C L E
From the 1Department of Medicine, George Washington University School of Medicine, Washington, DC;
the 2Physicians Committee for Responsible Medicine, Washington, DC; the 3Department of Nutritional
Sciences, Faculty of Medicine, University of Toronto, and the Clinical Nutrition and Risk Factor Modification
Center, St. Michaels Hospital, Toronto, Canada; the 4Department of Nutrition, School of Public Health,
University of North Carolina, Chapel Hill, North Carolina; and 5Private practice, Arlington, Virginia.
Address correspondence and reprint requests to Neal D. Barnard, MD, 5100 Wisconsin Ave., Suite 400,
Washington, DC 20016. E-mail: nbarnard@pcrm.org.
Received for publication 20 March 2006 and accepted in revised form 15 May 2006.
Abbreviations: ADA, American Diabetes Association.
A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion
factors for many substances.
DOI: 10.2337/dc06-0606. Clinical trial reg. no. NCT00276939, clinicaltrials.gov.
2006 by the American Diabetes Association.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby
marked advertisement in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
used in the absence of exercise, was associated with increased insulin sensitivity
and reduced body weight in nondiabetic
overweight women (4).
We therefore conducted a randomized controlled trial of a vegan diet with
exercise held constant to test the hypothesis that, in individuals with type 2 diabetes, a low-fat plant-based diet improves
glycemic, plasma lipid, and weight control compared with a diet based on current ADA guidelines.
RESEARCH DESIGN AND
METHODS Individuals with type 2
diabetes, defined by a fasting plasma glucose concentration 6.9 mmol/l on two
occasions or a prior diagnosis of type 2
diabetes with the use of hypoglycemic
medications for 6 months, were recruited through newspaper advertisements in the Washington, DC, area on
two occasions (October 2003 through
December 2003 and October 2004
through December 2004) to complete the
study from January 2004 through June
2004 and January 2005 through June
2005, respectively. Exclusion criteria
were an HbA1c (A1C) 6.5 or 10.5%,
use of insulin for 5 years, current smoking, alcohol or drug abuse, pregnancy,
unstable medical status, and current use
of a low-fat vegetarian diet. The protocol
was approved by the George Washington
University Institutional Review Board. All
participants gave written informed
consent.
A1C was assayed using affinity chromatography on an Abbott IMx analyzer
(5). Volunteers were ranked in order of
A1C concentrations and randomly assigned in sequential pairs, using a random-number table, to a low-fat vegan diet
or a diet following the 2003 ADA guidelines (6) for 22 weeks. Because assignment was done simultaneously, allocation
concealment was unnecessary.
The vegan diet (10% of energy from
fat, 15% protein, and 75% carbohydrate)
consisted of vegetables, fruits, grains, and
legumes. Participants were asked to avoid
animal products and added fats and to
1777
n
Age (years)
Sex
Male
Female
Race, ethnicity
Black, non-Hispanic
White, non-Hispanic
White, Hispanic
Asian, non-Hispanic
Marital status
Not married
Married
Education
High school, partial or graduate
College, partial or graduate
Graduate degree
Occupation
Service occupation
Technical, sales, administrative
Professional or managerial
Retired
On insulin
On metformin
On sulfonylurea
On thiazolidinedione
On other diabetes medications
On blood pressure medications
On lipid-lowering medications
History of eye involvement
History of renal involvement
History of neuropathy
Mean BMI (kg/m2)
25 kg/m2
2529.9 kg/m2
30 kg/m2
Vegan group
ADA group
49
56.7 (3582)
50
54.6 (2780)
22 (45)
27 (55)
17 (34)
33 (66)
22 (45)
21 (43)
4 (8)
2 (4)
22 (44)
22 (44)
2 (4)
4 (8)
20 (41)
29 (59)
26 (52)
24 (48)
6 (12)
26 (53)
17 (35)
3 (6)
25 (50)
22 (44)
3 (6)
16 (33)
15 (31)
15 (31)
11 (22)
34 (69)
25 (51)
16 (33)
1 (2)
31 (63)
27 (55)
9 (18)
6 (12)
18 (37)
33.9
5 (10)
14 (29)
30 (61)
7 (14)
18 (36)
21 (42)
4 (8)
5 (10)
39 (78)
29 (58)
15 (30)
2 (4)
38 (76)
27 (54)
10 (20)
4 (8)
24 (48)
35.9
2 (4)
5 (10)
43 (86)
P value
0.29
0.26
0.71*
0.08
0.69
0.04
0.09
0.33
0.49
0.78
0.57
0.17
0.88
0.82
0.48
0.25
0.18
Data are mean (range) or n (%) unless otherwise indicated. P values refer to t test for continuous variables and
2 for categorical variables. *P value calculated for race distribution; for ethnicity (Hispanic vs. non-Hispanic), P 0.39.
1780
159.3 31.9
47.3 16.9
112.0 31.9
3.7 1.2
88.0 27.8
23.0 10.2
119.7 56.0
2.03 0.21
187.0 37.4
52.3 19.7
134.7 39.2
4.0 1.6
104.4 32.9
26.2 14.4
148.1 112.5
2.08 0.28
14.6 17.8
5
33.0 51.8
12
120.0 18.3
72.8 10.2
6.84 0.84
7.12 1.80
128.2 32.4
95.9 22.4
33.8 7.2
110.3 17.8
119.1 17.3
0.93 0.07
8.07 1.24
9.85 2.95
177.4 53.2
102.4 23.6
36.1 7.5
115.3 17.9
123.3 17.4
0.94 0.08
123.8 17.1
77.9 11.1
7.1 1.0
7.11 1.97
128.0 35.5
91.1 22.4
31.8 7.5
105.5 18.1
114.5 17.8
0.92 0.07
8.0 1.1
9.08 2.95
163.5 53.2
97.0 22.9
33.9 7.8
110.8 18.4
118.4 17.8
0.94 0.08
22 weeks
28.5 80.0
0.05 0.17
3.2 10.0
27.7 28.5*
5.0 7.1*
22.7 28.2*
0.3 0.9
16.4 30.6
3.8 12.6
5.1 8.3*
18.4 39.0
7
1.23 1.38
2.73 3.05
49.2 55.0
6.5 4.3*
2.3 1.5*
5.0 3.7*
4.1 2.8*
0.01 0.03
1.0 1.2*
1.97 2.68*
35.5 48.3*
5.8 4.4*
2.1 1.5*
5.3 4.4*
3.9 3.4*
0.02 0.03
Change
158.1 133.1
2.11 0.25
26.8 13.8
198.9 44.0
49.8 14.5
149.0 44.1
4.3 1.7
118.5 41.5
122.9 15.1
80.0 10.5
55.0 263.1
8
7.88 0.93
8.90 2.05
160.3 37.0
100.0 19.4
36.0 5.8
113.3 13.1
121.7 12.1
0.93 0.07
7.9 1.0
8.90 2.26
160.4 40.7
99.3 21.0
35.9 7.0
112.3 14.9
121.3 12.7
0.93 0.07
Baseline
0.38 1.11
1.57 2.50
28.2 45.0
3.1 3.4*
1.1 1.2*
2.3 4.2
3.1 3.3*
0.00 0.04
0.6 1.1
1.92 2.48*
34.6 44.7*
4.3 4.4*
1.5 1.5*
2.8 4.7*
3.8 3.9*
0.01 0.04
4.4 12.4
24.2 30.5*
3.2 11.0
21.0 31.5*
0.4 1.2
15.4 25.1*
3.6 13.7
3.3 8.8
22.3 10.0
174.6 36.2
46.6 11.8
128.0 35.0
3.9 1.2
103.1 33.3
119.4 16.5
76.7 11.1
7.50 1.03
7.34 2.05
132.2 36.9
96.9 19.1
34.9 5.9
111.0 13.5
118.6 11.6
0.94 0.08
7.4 1.0
6.98 1.91
125.8 34.4
95.0 20.9
34.3 7.3
109.5 14.7
117.5 12.2
0.93 0.07
Change
Effect size
0.87
0.61
0.60
0.56
0.34
0.78
0.92
0.86
0.93
0.30
0.45
NA
0.01
0.12
0.12
0.001
0.001
0.017
0.23
0.10
0.09
0.92
0.92
0.08
0.08
0.008
0.94
0.003
P value
1781
22.2 58.5
0.04 0.16
3.5 10.5
190.5 36.8
54.6 21.0
135.9 38.4
3.9 1.5
107.3 34.3
33.5 21.5*
6.0 6.8*
27.6 21.1*
0.3 0.6
22.6 22.0*
0.98
0.68
0.89
0.01
0.14
0.05
0.98
0.02
Data are means SD unless otherwise indicated. Listed P values are for comparisons of between-group (vegan vs. ADA) changes (baseline to 22 weeks).*P 0.0001, P 0.001, P 0.01, and P 0.05 for
within-group changes. Blood pressure was not determined on one vegan group participant due to equipment failure. When triglycerides exceeded 400 mg/dl, LDL was calculated via direct-LDL; two ADA-group
individuals were excluded due to lack of sufficient plasma samples. SI conversion: to convert HDL, LDL, and total cholesterol to mmol/l, multiply by 0.0259; for tryiglycerides, multiply by 0.0113.
Figure 1A1C at baseline and at 11 and 22 weeks. Open circles: all vegan group participants
(n 49); closed circles: medication-stable vegan group participants (n 24); open squares: all
ADA group participants (n 50); closed squares: medication-stable ADA group participants (n
33). Error bars represent SE of the mean. P 0.09 for between-group comparison from baseline
to 22 weeks for full sample; P 0.01 for medication-stable participants (vegan vs. ADA).
portions can, as a result, easily exceed recommended limits on saturated fat. In contrast, the vegan diet includes no animal
fat, so variations in food quantity are less
likely to result in substantial increases in
saturated fat intake. Because the vegan
diet is based on the elimination of certain
foods, it may be easier to understand than
regimens that limit quantities of certain
foods without proscribing any. The acceptability of low-fat vegan diets in clinical studies is similar to that of seemingly
more moderate diets (27).
This studys strengths include its
analysis of dependent measures without
regard to variations in dietary adherence
and applicability outside the research setting. A study limitation was that both diets made participants vulnerable to the
hypoglycemic effect of their diabetes
medications, resulting in medication reductions that confound the interpretation
of A1C changes and necessitating a subgroup analysis of medication-stable participants. Because these episodes
occurred early in the trial, there was no
opportunity to bring interim laboratory
values forward. Also, most study participants were taking antihypertensive medications, which may have blunted the
effect of diet on blood pressure.
In conclusion, in individuals with
type 2 diabetes participating in a 22-week
clinical trial, both a low-fat vegan diet and
a diet following ADA guidelines improved
glycemic control; however, the changes
were greater in the vegan group. Further
research is necessary to establish longerterm diet effects and sustainability.
Acknowledgments The study was supported by grant R01 DK059362-01A2 from
the National Institute of Diabetes and Digestive and Kidney Diseases and by the Diabetes
Action Research and Education Foundation.
The authors express appreciation to Paul
Poppen, PhD, for statistical analyses.
References
1. Jenkins DJA, Kendall CWC, Marchie A,
Jenkins AL, Augustin LSA, Ludwig DS,
Barnard ND, Anderson JW: Type 2 diabetes and the vegetarian diet. Am J Clin Nutr
78:610S 616S, 2003
2. Fraser GE: Vegetarianism and obesity, hypertension, diabetes, and arthritis. In Diet,
Life Expectancy, and Chronic Disease. Oxford, U.K., Oxford University Press,
2003, p. 129 148
3. Nicholson AS, Sklar M, Barnard ND, Gore
S, Sullivan R, Browning S: Toward improved management of NIDDM: a ranDIABETES CARE, VOLUME 29, NUMBER 8, AUGUST 2006
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