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SAN FRANCISCO – Adults with prediabetes, supplemented daily with vitamin D for 2.5 years, were just as likely to develop type 2 diabetes during follow-up as similar placebo-treated patients, regardless of their age. initial status in vitamin D, according to data from the study presented here and published in The New England Medical Journal.
Recent observational studies suggest that vitamin D has extraskeletal benefits, including for the prevention of diabetes, while over-the-counter vitamin D sales have increased significantly between 2001 and 2009, with the media reporting these results. , Myrlene A. Staten, MD, a project scientist from the NIH's National Institute of Diabetes and Digestive and Kidney Diseases, said at a presentation on the testing of vitamin D and type 2 diabetes (D2d ) at the scientific sessions of the American Diabetes Association.
"It has become important to determine if all this vitamin D supplementation that people take is justified?" Said Staten. "NIDDK and the Bureau of Dietary Supplements and the ADA supported this study to determine if people at risk of type 2 diabetes would receive 4,000 IU of vitamin D a day, would that reduce the rate of progression of type 2 diabetes? "
Study the design
Staten and colleagues badyzed data from 2,423 participants aged 30 years or older, whose BMI was between 24 kg / m² and 42 kg / m² and who fulfilled at least two of the three pre-diabetes blood glucose fasting plasma glucose level between 100 mg / dL and 125 mg / dL, a plasma glucose level between 140 mg / dL and 199 mg / dL after a 2 hour oral glucose tolerance test or HbA1c between 5.7% and 6.4% (44.8% of women, mean age, 60 years, average BMI, 32 kg / m², 33.3% non-white). Between October 2013 and February 2017, researchers randomly divided participants between 4,000 IU vitamin D per day (n = 1,211, baseline average vitamin D, 27.7 ng / mL) or placebo (n = 1212) and an average vitamin D level of 28.2 ng / mL. ), irrespective of serum 25-hydroxyvitamin D.
"For various reasons, we specifically designed this study to be agnostic against 25-hydroxyvitamin D levels initially, but also during the real-time study," Anastbadios G. Pittas, MD, Co-director of the Center for Diabetes and Lipids and professor at the Faculty of Medicine at Tufts University in Boston, said during the presentation. "We expected participants to reach sufficient levels, which may have limited the ability of the study to detect a statistically significant event."
In order to maximize the ability to observe a therapeutic effect, the researchers asked participants to refrain from using diabetes-specific or weight-loss medications during the trial and to limit the use of drugs. Use of vitamin D apart from testing at 1,000 IU a day, including taking multivitamins. The primary endpoint was recent-onset diabetes, with a target number of diabetes events of 508. The researchers used proportional risk models of Cox to calculate diabetes heart failure. Recent appearance between the two groups.
At 24 months, the mean serum 25- (OH) D was 54.3 ng / mL in the vitamin D group and 28.8 ng / mL in the placebo group. After a median follow-up of 2.5 years, new diabetes was observed in 293 participants in the vitamin D group (9.39 events per 100 person-years) and 323 participants in the placebo group (10.66 events per 100 person-years ).
NOT o protective effect
Compared with placebo badigned to participants, the newly emerging diabetes heart failure in patients badigned to vitamin D was 0.88 (95% CI, 0.75-1.04). There were no differences between groups for adverse events.
In a post-hoc badysis of data from participants with a baseline vitamin D level of less than 12 ng / mL (n = 103), the researchers found that diabetes HR in the vitamin D group was 0 , 38 (95% CI, 0.18). -0.8). According to the researchers, among participants whose baseline vitamin D level was 12 ng / mL or higher (n = 2,319), the HR level in the vitamin D group for the new diabetes was 0.92 ( 95% CI, 0.78-1.08).
In an exploratory, protocol-by-protocol badysis, which excluded follow-up data from participants who started anti-diabetic or anti-diabetic medication, stopped taking pills or took vitamin D supplements outside of the trial greater than 1000 IU per day, 266 participants (22%) in the vitamin D group, and 304 patients (25.1%) in the placebo group developed type 2 diabetes, for a CF of 0.84 (CI to 95%, 0.71-1).
In the study, the researchers noted that the high percentage of participants with adequate levels of vitamin D could limit the ability of the test to detect a significant effect.
"In American adults at high risk of type 2 diabetes without vitamin D insufficiency, vitamin D at 4000 IU per day for a mean follow-up of 2 years did not significantly reduce the risk of diabetes, but it did not lead to not significantly more kidney stones, high serum calcium or elevated levels [glomerular filtration rate]Said Pittas.
At a question-and-answer session after the presentation, Mr. Staten said the researchers still intended to badyze patient data at the individual level and to evaluate the patient. 39; effect of several variables on the secretion of insulin.
"As a result of a significant reduction in the risk of type 2 diabetes, D2d is a well-done test that has answered this question," said Staten.
Signal in vitamin D deficiency
In the commentary accompanying the study, Deborah J. Wexler, MD, Associate Professor of Medicine at the Mbadachusetts General Hospital Diabetes Center and at Harvard Medical School, wrote that the CF observed "does not exclude" a modest benefit from vitamin D supplementation.
"All the benefits of vitamin D for the prevention of diabetes, if any, are modest and clearly do not belong to a sufficient vitamin D population," wrote Wexler. "Targeting populations with vitamin D levels below 12 ng / mL, many of which have additional risk factors for diabetes, would affect beta cell function and progression to type 2 diabetes." remains unresolved. " – by ReGina Schaffer
Reference s :
Pittas AG, et al. The study on vitamin D and type 2 diabetes (D2d) is a multicenter randomized controlled trial for the prevention of diabetes. Presented at: American Diabetes Association 79th Scientific Sessions; June 7-11, 2019; San Francisco.
Pittas AG, et al. NOT Engl J Med. 2019; doi: 10.1056 / NEJMoa1900906.
Wexler DJ. NOT Engl J Med. 2019; doi: 10.1056 / NEJMe1906815.
Disclosures: Pittas and Staten do not report any relevant financial information. Please consult the study for the relevant financial information of all other authors. Wexler reports that she sat on a data monitoring committee for Novo Nordisk.
SAN FRANCISCO – Adults with prediabetes, supplemented daily with vitamin D for 2.5 years, were just as likely to develop type 2 diabetes during follow-up as similar placebo-treated patients, regardless of their age. initial status in vitamin D, according to data from the study presented here and published in The New England Medical Journal.
Recent observational studies suggest that vitamin D has extraskeletal benefits, including for the prevention of diabetes, while over-the-counter vitamin D sales have increased significantly between 2001 and 2009, with the media reporting these results. , Myrlene A. Staten, MD, a project scientist from the NIH's National Institute of Diabetes and Digestive and Kidney Diseases, said at a presentation on the testing of vitamin D and type 2 diabetes (D2d ) at the scientific sessions of the American Diabetes Association.
"It has become important to determine if all this vitamin D supplementation that people take is justified?" Said Staten. "NIDDK and the Bureau of Dietary Supplements and the ADA supported this study to determine if people at risk of type 2 diabetes would receive 4,000 IU of vitamin D a day, would that reduce the rate of progression of type 2 diabetes? "
Study the design
Staten and colleagues badyzed data from 2,423 participants aged 30 years or older, whose BMI was between 24 kg / m² and 42 kg / m² and who fulfilled at least two of the three pre-diabetes blood glucose fasting plasma glucose level between 100 mg / dL and 125 mg / dL, a plasma glucose level between 140 mg / dL and 199 mg / dL after a 2 hour oral glucose tolerance test or HbA1c between 5.7% and 6.4% (44.8% of women, mean age, 60 years, average BMI, 32 kg / m², 33.3% non-white). Between October 2013 and February 2017, researchers randomly divided participants between 4,000 IU vitamin D per day (n = 1,211, baseline average vitamin D, 27.7 ng / mL) or placebo (n = 1212) and an average vitamin D level of 28.2 ng / mL. ), irrespective of serum 25-hydroxyvitamin D.
"For various reasons, we specifically designed this study to be agnostic against 25-hydroxyvitamin D levels initially, but also during the real-time study," Anastbadios G. Pittas, MD, Co-director of the Center for Diabetes and Lipids and professor at the Faculty of Medicine at Tufts University in Boston, said during the presentation. "We expected participants to reach sufficient levels, which may have limited the ability of the study to detect a statistically significant event."
PAGE BREAK
In order to maximize the ability to observe a therapeutic effect, the researchers asked participants to refrain from using diabetes-specific or weight-loss medications during the trial and to limit the use of drugs. Use of vitamin D apart from testing at 1,000 IU a day, including taking multivitamins. The primary endpoint was recent-onset diabetes, with a target number of diabetes events of 508. The researchers used proportional risk models of Cox to calculate diabetes heart failure. Recent appearance between the two groups.
At 24 months, the mean serum 25- (OH) D was 54.3 ng / mL in the vitamin D group and 28.8 ng / mL in the placebo group. After a median follow-up of 2.5 years, new diabetes was observed in 293 participants in the vitamin D group (9.39 events per 100 person-years) and 323 participants in the placebo group (10.66 events per 100 person-years ).
NOT o protective effect
Compared with placebo badigned to participants, the newly emerging diabetes heart failure in patients badigned to vitamin D was 0.88 (95% CI, 0.75-1.04). There were no differences between groups for adverse events.
In a post-hoc badysis of data from participants with a baseline vitamin D level of less than 12 ng / mL (n = 103), the researchers found that diabetes HR in the vitamin D group was 0 , 38 (95% CI, 0.18). -0.8). According to the researchers, among participants whose baseline vitamin D level was 12 ng / mL or higher (n = 2,319), the HR level in the vitamin D group for the new diabetes was 0.92 ( 95% CI, 0.78-1.08).
In an exploratory, protocol-by-protocol badysis, which excluded follow-up data from participants who started anti-diabetic or anti-diabetic medication, stopped taking pills or took vitamin D supplements outside of the trial greater than 1000 IU per day, 266 participants (22%) in the vitamin D group, and 304 patients (25.1%) in the placebo group developed type 2 diabetes, for a CF of 0.84 (CI to 95%, 0.71-1).
In the study, the researchers noted that the high percentage of participants with adequate levels of vitamin D could limit the ability of the test to detect a significant effect.
"In American adults at high risk of type 2 diabetes without vitamin D insufficiency, vitamin D at 4000 IU per day for a mean follow-up of 2 years did not significantly reduce the risk of diabetes, but it did not lead to not significantly more kidney stones, high serum calcium or elevated levels [glomerular filtration rate]Said Pittas.
At a question-and-answer session after the presentation, Mr. Staten said the researchers still intended to badyze patient data at the individual level and to evaluate the patient. 39; effect of several variables on the secretion of insulin.
PAGE BREAK
"As a result of a significant reduction in the risk of type 2 diabetes, D2d is a well-done test that has answered this question," said Staten.
Signal in vitamin D deficiency
In the commentary accompanying the study, Deborah J. Wexler, MD, Associate Professor of Medicine at the Mbadachusetts General Hospital Diabetes Center and at Harvard Medical School, wrote that the CF observed "does not exclude" a modest benefit from vitamin D supplementation.
"All the benefits of vitamin D for the prevention of diabetes, if any, are modest and clearly do not belong to a sufficient vitamin D population," wrote Wexler. "Targeting populations with vitamin D levels below 12 ng / mL, many of which have additional risk factors for diabetes, would affect beta cell function and progression to type 2 diabetes." remains unresolved. " – by ReGina Schaffer
Reference s :
Pittas AG, et al. The study on vitamin D and type 2 diabetes (D2d) is a multicenter randomized controlled trial for the prevention of diabetes. Presented at: American Diabetes Association 79th Scientific Sessions; June 7-11, 2019; San Francisco.
Pittas AG, et al. NOT Engl J Med. 2019; doi: 10.1056 / NEJMoa1900906.
Wexler DJ. NOT Engl J Med. 2019; doi: 10.1056 / NEJMe1906815.
Disclosures: Pittas and Staten do not report any relevant financial information. Please consult the study for the relevant financial information of all other authors. Wexler reports that she sat on a data monitoring committee for Novo Nordisk.
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