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

Song Y, Cook NR, Albert CM, Van Denburgh M, Manson JE - Diabetes (2009)

Bottom Line: Also, there was no evidence for effect modifications by baseline intakes of dietary folate, vitamin B6, and vitamin B12.In a sensitivity analysis, the result remained for women compliant with their study pills (0.92 [0.76-1.10]; P = 0.36).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.

View Article: PubMed Central - PubMed

Affiliation: Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. ysong3@rics.bwh.harvard.edu.

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 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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Related in: MedlinePlus

Cumulative incidence of self-reported type 2 diabetes by randomized treatment assignment (active treatment versus placebo) in the WAFACS.
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Figure 2: Cumulative incidence of self-reported type 2 diabetes by randomized treatment assignment (active treatment versus placebo) in the WAFACS.

Mentions: Overall, there was no significant effect of folic acid/B vitamins on the development of type 2 diabetes compared with the placebo group (Table 2 and Fig. 2). In total, there were 245 incident cases (11.5%) in the active treatment group and 259 (12.2%) in the placebo group (172.5/10,000 person-years vs. 184.8/10,000 person-years), corresponding to an overall RR of 0.94 (95% CI 0.79–1.11; P = 0.46) after controlling for age and antioxidant treatment assignments (Table 2). Figure 2 shows the cumulative incidence of type 2 diabetes events among women in the treatment and placebo groups by year of follow-up. There appeared to be a trend toward a modest reduction in risk of type 2 diabetes for the treatment group versus placebo group over the follow-up period, but the log-rank test for the overall difference was not statistically significant (P for log-rank test = 0.44) (Fig. 2).


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

Song Y, Cook NR, Albert CM, Van Denburgh M, Manson JE - Diabetes (2009)

Cumulative incidence of self-reported type 2 diabetes by randomized treatment assignment (active treatment versus placebo) in the WAFACS.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2712772&req=5

Figure 2: Cumulative incidence of self-reported type 2 diabetes by randomized treatment assignment (active treatment versus placebo) in the WAFACS.
Mentions: Overall, there was no significant effect of folic acid/B vitamins on the development of type 2 diabetes compared with the placebo group (Table 2 and Fig. 2). In total, there were 245 incident cases (11.5%) in the active treatment group and 259 (12.2%) in the placebo group (172.5/10,000 person-years vs. 184.8/10,000 person-years), corresponding to an overall RR of 0.94 (95% CI 0.79–1.11; P = 0.46) after controlling for age and antioxidant treatment assignments (Table 2). Figure 2 shows the cumulative incidence of type 2 diabetes events among women in the treatment and placebo groups by year of follow-up. There appeared to be a trend toward a modest reduction in risk of type 2 diabetes for the treatment group versus placebo group over the follow-up period, but the log-rank test for the overall difference was not statistically significant (P for log-rank test = 0.44) (Fig. 2).

Bottom Line: Also, there was no evidence for effect modifications by baseline intakes of dietary folate, vitamin B6, and vitamin B12.In a sensitivity analysis, the result remained for women compliant with their study pills (0.92 [0.76-1.10]; P = 0.36).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.

View Article: PubMed Central - PubMed

Affiliation: Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. ysong3@rics.bwh.harvard.edu.

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 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.

Show MeSH
Related in: MedlinePlus