Baseline characteristics of the Vitamin D and type 2 diabetes (D2d) study

A contemporary prediabetes cohort that will inform diabetes prevention efforts

Erin S. LeBlanc, Richard E. Pratley, Bess Dawson-Hughes, Myrlene A. Staten, Patricia R. Sheehan, Michael R. Lewis, Anne Peters, Sun H. Kim, Ranee Chatterjee, Vanita R. Aroda, Chhavi Chadha, Lisa M. Neff, Irwin G. Brodsky, Clifford Rosen, Cyrus V. Desouza, John P. Foreyt, Daniel S. Hsia, Karen Johnson, Philip Raskin, Sangeeta R. Kashyap & 6 others Patrick O'Neil, Lawrence S. Phillips, Neda Rasouli, Emilia P. Liao, David C. Robbins, Anastassios G. Pittas

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

OBJECTIVE: To describe baseline characteristics of the Vitamin D and Type 2 Diabetes (D2d) study, the first large U.S. diabetes prevention clinical trial to apply current American Diabetes Association (ADA) criteria for prediabetes. RESEARCH DESIGN AND METHODS: This is a multicenter (n = 22 sites), randomized, double-blind, placebo-controlled, primary prevention clinical trial testing effects of oral daily 4,000 IU cholecalciferol (D3) compared with placebo on incident diabetes in U.S. adults at risk for diabetes. Eligible participants were at risk for diabetes, defined as not meeting criteria for diabetes but meeting at least two 2010 ADA glycemic criteria for prediabetes: fasting plasma glucose (FPG) 100-125 mg/dL, 2-h postload glucose (2hPG) after a 75-g oral glucose load 140-199 mg/dL, and/or a hemoglobin A1c (HbA1c) 5.7-6.4% (39-46 mmol/mol). RESULTS: A total of 2, 423 participants (45% of whom were women and 33% nonwhite) were randomized to cholecalciferol or placebo. Mean (SD) age was 59 (9.9) years and BMI 32 (4.5) kg/m2. Thirty-five percent met all three prediabetes criteria, 49% met the FPG/HbA1c criteria only, 9.5% met the 2hPG/FPG criteria only, and 6.3% met the 2hPG/HbA1c criteria only. Black participants had the highest mean HbA1c and lowest FPG concentration compared with white, Asian, and other races (P < 0.01); 2hPG concentration did not differ among racial groups. When compared with previous prediabetes cohorts, the D2d cohort had lower mean 2hPG concentration but similar HbA1c and FPG concentrations. CONCLUSIONS: D2d will establish whether Vitamin D supplementation lowers risk of diabetes and will inform about the natural history of prediabetes per contemporary ADA criteria.

Original languageEnglish (US)
Pages (from-to)1590-1599
Number of pages10
JournalDiabetes care
Volume41
Issue number8
DOIs
StatePublished - Aug 1 2018

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Ergocalciferols
Prediabetic State
Type 2 Diabetes Mellitus
Glucose
Fasting
Hemoglobins
Cholecalciferol
Placebos
Clinical Trials
Primary Prevention
Vitamin D
Research Design

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

Cite this

LeBlanc, E. S., Pratley, R. E., Dawson-Hughes, B., Staten, M. A., Sheehan, P. R., Lewis, M. R., ... Pittas, A. G. (2018). Baseline characteristics of the Vitamin D and type 2 diabetes (D2d) study: A contemporary prediabetes cohort that will inform diabetes prevention efforts. Diabetes care, 41(8), 1590-1599. https://doi.org/10.2337/dc18-0240

Baseline characteristics of the Vitamin D and type 2 diabetes (D2d) study : A contemporary prediabetes cohort that will inform diabetes prevention efforts. / LeBlanc, Erin S.; Pratley, Richard E.; Dawson-Hughes, Bess; Staten, Myrlene A.; Sheehan, Patricia R.; Lewis, Michael R.; Peters, Anne; Kim, Sun H.; Chatterjee, Ranee; Aroda, Vanita R.; Chadha, Chhavi; Neff, Lisa M.; Brodsky, Irwin G.; Rosen, Clifford; Desouza, Cyrus V.; Foreyt, John P.; Hsia, Daniel S.; Johnson, Karen; Raskin, Philip; Kashyap, Sangeeta R.; O'Neil, Patrick; Phillips, Lawrence S.; Rasouli, Neda; Liao, Emilia P.; Robbins, David C.; Pittas, Anastassios G.

In: Diabetes care, Vol. 41, No. 8, 01.08.2018, p. 1590-1599.

Research output: Contribution to journalArticle

LeBlanc, ES, Pratley, RE, Dawson-Hughes, B, Staten, MA, Sheehan, PR, Lewis, MR, Peters, A, Kim, SH, Chatterjee, R, Aroda, VR, Chadha, C, Neff, LM, Brodsky, IG, Rosen, C, Desouza, CV, Foreyt, JP, Hsia, DS, Johnson, K, Raskin, P, Kashyap, SR, O'Neil, P, Phillips, LS, Rasouli, N, Liao, EP, Robbins, DC & Pittas, AG 2018, 'Baseline characteristics of the Vitamin D and type 2 diabetes (D2d) study: A contemporary prediabetes cohort that will inform diabetes prevention efforts', Diabetes care, vol. 41, no. 8, pp. 1590-1599. https://doi.org/10.2337/dc18-0240
LeBlanc, Erin S. ; Pratley, Richard E. ; Dawson-Hughes, Bess ; Staten, Myrlene A. ; Sheehan, Patricia R. ; Lewis, Michael R. ; Peters, Anne ; Kim, Sun H. ; Chatterjee, Ranee ; Aroda, Vanita R. ; Chadha, Chhavi ; Neff, Lisa M. ; Brodsky, Irwin G. ; Rosen, Clifford ; Desouza, Cyrus V. ; Foreyt, John P. ; Hsia, Daniel S. ; Johnson, Karen ; Raskin, Philip ; Kashyap, Sangeeta R. ; O'Neil, Patrick ; Phillips, Lawrence S. ; Rasouli, Neda ; Liao, Emilia P. ; Robbins, David C. ; Pittas, Anastassios G. / Baseline characteristics of the Vitamin D and type 2 diabetes (D2d) study : A contemporary prediabetes cohort that will inform diabetes prevention efforts. In: Diabetes care. 2018 ; Vol. 41, No. 8. pp. 1590-1599.
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abstract = "OBJECTIVE: To describe baseline characteristics of the Vitamin D and Type 2 Diabetes (D2d) study, the first large U.S. diabetes prevention clinical trial to apply current American Diabetes Association (ADA) criteria for prediabetes. RESEARCH DESIGN AND METHODS: This is a multicenter (n = 22 sites), randomized, double-blind, placebo-controlled, primary prevention clinical trial testing effects of oral daily 4,000 IU cholecalciferol (D3) compared with placebo on incident diabetes in U.S. adults at risk for diabetes. Eligible participants were at risk for diabetes, defined as not meeting criteria for diabetes but meeting at least two 2010 ADA glycemic criteria for prediabetes: fasting plasma glucose (FPG) 100-125 mg/dL, 2-h postload glucose (2hPG) after a 75-g oral glucose load 140-199 mg/dL, and/or a hemoglobin A1c (HbA1c) 5.7-6.4{\%} (39-46 mmol/mol). RESULTS: A total of 2, 423 participants (45{\%} of whom were women and 33{\%} nonwhite) were randomized to cholecalciferol or placebo. Mean (SD) age was 59 (9.9) years and BMI 32 (4.5) kg/m2. Thirty-five percent met all three prediabetes criteria, 49{\%} met the FPG/HbA1c criteria only, 9.5{\%} met the 2hPG/FPG criteria only, and 6.3{\%} met the 2hPG/HbA1c criteria only. Black participants had the highest mean HbA1c and lowest FPG concentration compared with white, Asian, and other races (P < 0.01); 2hPG concentration did not differ among racial groups. When compared with previous prediabetes cohorts, the D2d cohort had lower mean 2hPG concentration but similar HbA1c and FPG concentrations. CONCLUSIONS: D2d will establish whether Vitamin D supplementation lowers risk of diabetes and will inform about the natural history of prediabetes per contemporary ADA criteria.",
author = "LeBlanc, {Erin S.} and Pratley, {Richard E.} and Bess Dawson-Hughes and Staten, {Myrlene A.} and Sheehan, {Patricia R.} and Lewis, {Michael R.} and Anne Peters and Kim, {Sun H.} and Ranee Chatterjee and Aroda, {Vanita R.} and Chhavi Chadha and Neff, {Lisa M.} and Brodsky, {Irwin G.} and Clifford Rosen and Desouza, {Cyrus V.} and Foreyt, {John P.} and Hsia, {Daniel S.} and Karen Johnson and Philip Raskin and Kashyap, {Sangeeta R.} and Patrick O'Neil and Phillips, {Lawrence S.} and Neda Rasouli and Liao, {Emilia P.} and Robbins, {David C.} and Pittas, {Anastassios G.}",
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T1 - Baseline characteristics of the Vitamin D and type 2 diabetes (D2d) study

T2 - A contemporary prediabetes cohort that will inform diabetes prevention efforts

AU - LeBlanc, Erin S.

AU - Pratley, Richard E.

AU - Dawson-Hughes, Bess

AU - Staten, Myrlene A.

AU - Sheehan, Patricia R.

AU - Lewis, Michael R.

AU - Peters, Anne

AU - Kim, Sun H.

AU - Chatterjee, Ranee

AU - Aroda, Vanita R.

AU - Chadha, Chhavi

AU - Neff, Lisa M.

AU - Brodsky, Irwin G.

AU - Rosen, Clifford

AU - Desouza, Cyrus V.

AU - Foreyt, John P.

AU - Hsia, Daniel S.

AU - Johnson, Karen

AU - Raskin, Philip

AU - Kashyap, Sangeeta R.

AU - O'Neil, Patrick

AU - Phillips, Lawrence S.

AU - Rasouli, Neda

AU - Liao, Emilia P.

AU - Robbins, David C.

AU - Pittas, Anastassios G.

PY - 2018/8/1

Y1 - 2018/8/1

N2 - OBJECTIVE: To describe baseline characteristics of the Vitamin D and Type 2 Diabetes (D2d) study, the first large U.S. diabetes prevention clinical trial to apply current American Diabetes Association (ADA) criteria for prediabetes. RESEARCH DESIGN AND METHODS: This is a multicenter (n = 22 sites), randomized, double-blind, placebo-controlled, primary prevention clinical trial testing effects of oral daily 4,000 IU cholecalciferol (D3) compared with placebo on incident diabetes in U.S. adults at risk for diabetes. Eligible participants were at risk for diabetes, defined as not meeting criteria for diabetes but meeting at least two 2010 ADA glycemic criteria for prediabetes: fasting plasma glucose (FPG) 100-125 mg/dL, 2-h postload glucose (2hPG) after a 75-g oral glucose load 140-199 mg/dL, and/or a hemoglobin A1c (HbA1c) 5.7-6.4% (39-46 mmol/mol). RESULTS: A total of 2, 423 participants (45% of whom were women and 33% nonwhite) were randomized to cholecalciferol or placebo. Mean (SD) age was 59 (9.9) years and BMI 32 (4.5) kg/m2. Thirty-five percent met all three prediabetes criteria, 49% met the FPG/HbA1c criteria only, 9.5% met the 2hPG/FPG criteria only, and 6.3% met the 2hPG/HbA1c criteria only. Black participants had the highest mean HbA1c and lowest FPG concentration compared with white, Asian, and other races (P < 0.01); 2hPG concentration did not differ among racial groups. When compared with previous prediabetes cohorts, the D2d cohort had lower mean 2hPG concentration but similar HbA1c and FPG concentrations. CONCLUSIONS: D2d will establish whether Vitamin D supplementation lowers risk of diabetes and will inform about the natural history of prediabetes per contemporary ADA criteria.

AB - OBJECTIVE: To describe baseline characteristics of the Vitamin D and Type 2 Diabetes (D2d) study, the first large U.S. diabetes prevention clinical trial to apply current American Diabetes Association (ADA) criteria for prediabetes. RESEARCH DESIGN AND METHODS: This is a multicenter (n = 22 sites), randomized, double-blind, placebo-controlled, primary prevention clinical trial testing effects of oral daily 4,000 IU cholecalciferol (D3) compared with placebo on incident diabetes in U.S. adults at risk for diabetes. Eligible participants were at risk for diabetes, defined as not meeting criteria for diabetes but meeting at least two 2010 ADA glycemic criteria for prediabetes: fasting plasma glucose (FPG) 100-125 mg/dL, 2-h postload glucose (2hPG) after a 75-g oral glucose load 140-199 mg/dL, and/or a hemoglobin A1c (HbA1c) 5.7-6.4% (39-46 mmol/mol). RESULTS: A total of 2, 423 participants (45% of whom were women and 33% nonwhite) were randomized to cholecalciferol or placebo. Mean (SD) age was 59 (9.9) years and BMI 32 (4.5) kg/m2. Thirty-five percent met all three prediabetes criteria, 49% met the FPG/HbA1c criteria only, 9.5% met the 2hPG/FPG criteria only, and 6.3% met the 2hPG/HbA1c criteria only. Black participants had the highest mean HbA1c and lowest FPG concentration compared with white, Asian, and other races (P < 0.01); 2hPG concentration did not differ among racial groups. When compared with previous prediabetes cohorts, the D2d cohort had lower mean 2hPG concentration but similar HbA1c and FPG concentrations. CONCLUSIONS: D2d will establish whether Vitamin D supplementation lowers risk of diabetes and will inform about the natural history of prediabetes per contemporary ADA criteria.

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