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current as of December 19, 2008.Online article and related content http://jama.ama-assn.org/cgi/content/full/300/23/2742. 2008;300(23):2742-2753 (doi:10.1001/jama.2008.808)

JAMA



David J. A. Jenkins; Cyril W. C. Kendall; Gail McKeown-Eyssen; et al.



Diet on Type 2 Diabetes: A Randomized TrialEffect of a LowGlycemic Index or a HighCereal Fiber

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Disease/ Myocardial Infarction; Endocrine Diseases; Diabetes MellitusCardiovascular System; Randomized Controlled Trial; Diet; Cardiovascular

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ORIGINAL CONTRIBUTION

EffectofaLow–GlycemicIndexoraHigh–CerealFiberDietonType2Diabetes

A Randomized Trial

David J. A. Jenkins, MDCyril W. C. Kendall, PhDGail McKeown-Eyssen, PhDRobert G. Josse, MB, BSJay Silverberg, MDGillian L. Booth, MDEdward Vidgen, BSc Andrea R. Josse, MScTri H. Nguyen, MScSorcha Corrigan, BScMonica S. Banach, BScSophie Ares, MA, RD, CDESandy Mitchell, BASc, RD Azadeh Emam, MScLivia S. A. Augustin, MScTina L. Parker, BASc, RDLawrence A. Leiter, MD

HE NEED FOR IMPLEMENTA

-tion of effective dietary strate-giesindiabetespreventionandmanagementhasbeenempha-sized by the success of diet and life-stylechangesinpreventingdiabetesinhigh-risk patients.

There is also con-cern that use of antihyperglycemicmedicationstoimproveglycemiccon-trol in type 2 diabetes may not alwayssignificantly improve cardiovascularoutcomes.

2-7

One dietary strategy aimed at im-provingbothdiabetescontrolandcar-diovascular risk factors is the use of low–glycemicindexdiets.

8-10

Thesedietshave been reported to benefit thecontrol of diabetes

; increase high-density lipoprotein cholesterol(HDL-C)

12,13

; lower serum triglycer-ide,plasminogenactivatorinhibitor1,and high-sensitivity C-reactive pro-tein(CRP)concentrations

14-16

; andre-duce diabetes incidence

8,9

and overallcardiovascular events.

Use of the



-glucosidasecarbohydrateabsorptionin-hibitor acarbose, which effectivelycreates a low–glycemic index diet by

Author Affiliations

are listed at the end of this article.

Corresponding Author:

David J. A. Jenkins, MD, De-partment of Nutritional Sciences, Faculty of Medi-cine, University of Toronto, 150 College St, Toronto,ON, M5S 3E2, Canada (cyril.kendall@utoronto.ca).

Context

Clinicaltrialsusingantihyperglycemicmedicationstoimproveglycemiccon-trol have not demonstrated the anticipated cardiovascular benefits. Low–glycemic in-dex diets may improve both glycemic control and cardiovascular risk factors for pa-tients with type 2 diabetes but debate over their effectiveness continues due to triallimitations.

Objective

To test the effects of low–glycemic index diets on glycemic control andcardiovascular risk factors in patients with type 2 diabetes.

Design, Setting, and Participants

A randomized, parallel study design at a Ca-nadianuniversityhospitalresearchcenterof210participantswithtype2diabetestreatedwithantihyperglycemicmedicationswhowererecruitedbynewspaperadvertisementand randomly assigned to receive 1 of 2 diet treatments each for 6 months betweenSeptember 16, 2004, and May 22, 2007.

Intervention

High–cereal fiber or low–glycemic index dietary advice.

MainOutcomeMeasures

AbsolutechangeinglycatedhemoglobinA

(HbA

),withfasting blood glucose and cardiovascular disease risk factors as secondary measures.

Results

Intheintention-to-treatanalysis,HbA

decreasedby−0.18%absoluteHbA

units (95% confidence interval [CI], −0.29% to −0.07%) in the high–cereal fiber dietcompared with −0.50% absolute HbA

units (95% CI, −0.61% to −0.39%) in thelow–glycemic index diet (



.001). There was also an increase of high-density lipo-proteincholesterolinthelow–glycemicindexdietby1.7mg/dL(95%CI,0.8-2.6mg/dL) compared with a decrease of high-density lipoprotein cholesterol by −0.2 mg/dL(95% CI, −0.9 to 0.5 mg/dL) in the high–cereal fiber diet (

=.005). The reduction indietaryglycemicindexrelatedpositivelytothereductioninHbA

concentration(

=0.35,



.001)andnegativelytotheincreaseinhigh-densitylipoproteincholesterol(

=−0.19,

=.009).

Conclusion

In patients with type 2 diabetes, 6-month treatment with a low–glycemic index diet resulted in moderately lower HbA

levels compared with a high–cereal fiber diet.

Trial Registration

clinicaltrials.gov identifier: NCT00438698

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slowing the rate of carbohydrate ab-sorption,similarlyreducednotonlytherateofprogressiontodiabetesinhigh-risk individuals but also the incidenceofhypertensionandtheriskofcardio-vascular disease.

17,18

Nonetheless, therelevance and practicality of applyingthe low–glycemic index dietary ap-proachtothetreatmentofdiabeteshasbeen questioned.

19-21

Furthermore, al-though meta-analyses of clinical stud-ieshaveindicatedabenefitindiabetesin terms of reduced glycated pro-teins,

individualtrialshaveoftenfailedtodemonstrateaclearbenefitforlow–glycemicindexdiets.

11,22

However,thesetrials have usually been of short dura-tion with relatively small numbers of participants.

An exception is a re-centlargerandlongertrial,

butinthatstudy, the mean baseline glycated he-moglobin A

(HbA

) concentrationwasalreadyrelativelylowat6.1%,thusmakingitdifficulttodemonstrateben-efit from the intervention.Our goal in this study was to assesstheeffectofalow–glycemicindexdietin an adequately powered study of pa-tients with type 2 diabetes controlledby oral medications with HbA

con-centrationsbetween6.5%and8.0%.Attheselevels,areductioninglycemiaandassociatedriskfactorsfordiabetescom-plicationsarelikelytobeobservedmoreclearly. We selected a high–cereal fi-ber diet treatment for its suggestedhealth benefits

8,9,23-25

for the compari-son so that the potential value of car-bohydrate foods could be emphasizedequally for both high–cereal fiber andlow–glycemic index interventions.

METHODS

Participants

Studyparticipantswererecruitedfromlocalnewspaperadvertisements.Outof 2220responsesbytelephone,981par-ticipants were considered potentiallyeligible and were invited to attend aninformation session at the Risk FactorModificationCenter,StMichael’sHos-pital,Toronto,Ontario,Canada,whereallstudyclinicalactivitytookplace.Of those participants invited, 658 at-tendedascreeningappointment.Atotalof389participantswereineligibleand269 were eligible; however, 6 partici-pants could not be contacted, 5 wereunable to start the study immediately,and 48 declined to continue. The re-maining210participantswererandom-ized(

IGURE

).RecruitmenttookplacebetweenJuly8,2004,andDecember5,2006, with the last follow-up visit onMay22,2007.Eligibleparticipantsweremen or postmenopausal women withtype 2 diabetes who were taking oralmedicationsotherthanacarbosetocon-trol their diabetes, with medicationsstable for the previous 3 months, andwhohadHbA

valuesatscreeningbe-tween 6.5% and 8.0% (to convert toproportion of total hemoglobin, mul-tiplyby0.01).Nonehadclinicallysig-nificant cardiovascular, renal, or liver

Figure 1.

Flow of Participants Through the Trial

23Dropped out

1Withdrawn (inconsistent antihyperglycemicmedications)11Lost interest4Diet-related reasons7Unrelated health issues2Physician refusal of consent6Job relocation3Travel difficulty1Family issues19Dropped out

1Withdrawn (increased HbA

)10Lost interest2Diet-related reasons3Unrelated health issues2Physician refusal of consent5Job relocation4Travel difficulty2Family issues104Randomized to receive high–cereal fiber diet5Did not receive intervention106Randomized to receive low–glycemic index diet6Did not receive intervention75Included in completer analysis80Included in completer analysis104Included in primary analysis106Included in primary analysis75Completed trial80Completed trial658Attended screening981Potentially eligible448Excluded389Ineligible48Declined participation5Unable to start study immediately6Could not be contacted186HbA

was too low (

6.5%)137HbA

was too high (

8.0%)66Other health issues2220Individuals responded to studyrecruitment advertisements210Randomized57Included in per-protocol analysis23Excluded2Antihyperglycemic medications increased13Antihyperglycemic medications decreased8Other

67Included in per-protocol analysis8Excluded3Antihyperglycemic medications increased3Antihyperglycemic medications decreased2Other

HbA

indicates glycated hemoglobin A

. The mean time to dropout for those participants who did not com-plete the end point assessment was 5.9 weeks for the high–cereal fiber diet and 3.4 weeks for the low–glycemic index diet.

Seventeen participants had morethan 1 reason fordropping out.Oneparticipantwho dropped outfromthehigh–cereal fiber diet had an antihyperglycemic medication dosage decrease and 1 participant who droppedout from the low–glycemic index diet had an antihyperglycemic medication dosage increase.