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Randomized Controlled Trial
. 2009 Aug;58(8):1921-8.
doi: 10.2337/db09-0087. Epub 2009 Jun 2.

Effect of homocysteine-lowering treatment with folic Acid and B vitamins on risk of type 2 diabetes in women: a randomized, controlled trial

Yiqing Song  1 , Nancy R Cook, Christine M Albert, Martin Van Denburgh, JoAnn E Manson
Affiliations
Randomized Controlled Trial

Effect of homocysteine-lowering treatment with folic Acid and B vitamins on risk of type 2 diabetes in women: a randomized, controlled trial

Yiqing Song et al. Diabetes. 2009 Aug.

Abstract

Objective: Homocysteinemia may play an etiologic role in the pathogenesis of type 2 diabetes by promoting oxidative stress, systemic inflammation, and endothelial dysfunction. We investigated whether homocysteine-lowering treatment by B vitamin supplementation prevents the risk of type 2 diabetes.

Research design and methods: The Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS), a randomized, double-blind, placebo-controlled trial of 5,442 female health professionals aged > or = 40 years with a history of cardiovascular disease (CVD) or three or more CVD risk factors, included 4,252 women free of diabetes at baseline. Participants were randomly assigned to either an active treatment group (daily intake of a combination pill of 2.5 mg folic acid, 50 mg vitamin B6, and 1 mg vitamin B12) or to the placebo group.

Results: During a median follow-up of 7.3 years, 504 women had an incident diagnosis of type 2 diabetes. Overall, there was no significant difference between the active treatment group and the placebo group in diabetes risk (relative risk 0.94 [95% CI 0.79-1.11]; P = 0.46), despite significant lowering of homocysteine levels. Also, there was no evidence for effect modifications by baseline intakes of dietary folate, vitamin B6, and vitamin B12. In a sensitivity analysis, the null result remained for women compliant with their study pills (0.92 [0.76-1.10]; P = 0.36).

Conclusions: Lowering homocysteine levels by daily supplementation with folic acid and vitamins B6 and B12 did not reduce the risk of developing type 2 diabetes among women at high risk for CVD.

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Figures

FIG. 1
FIG. 1
Flow diagram illustrating diabetes outcomes in the randomly assigned treatment of folic acid and vitamins B6 and B12 of the WAFACS. A total of 1,190 participants who had a diagnosis of diabetes at baseline were excluded in the analysis.
FIG. 2
FIG. 2
Cumulative incidence of self-reported type 2 diabetes by randomized treatment assignment (active treatment versus placebo) in the WAFACS.
FIG. 3
FIG. 3
RRs of self-reported type 2 diabetes by randomized intervention (active treatment versus placebo) within subgroups in the WAFACS. HT, hormone therapy.
See this image and copyright information in PMC

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