Rationale and design of the vitamin D and type 2 diabetes (D2d) study: A diabetes prevention trial

D2d Research Group, Anastassios G. Pittas, Bess Dawson-Hughes, Patricia R. Sheehan, Clifford J. Rosen, James H. Ware, William C. Knowler, Myrlene A. Staten, Russell Tracy, Michael R. Lewis, Lawrence Phillips, John Foreyt, Ranee Chatterjee, Richard Pratley, Chhavi Chadha, David Robbins, Anne Peters, Irwin Brodsky, Vanita Aroda, Cyrus Desouza & 13 others Leonid Poretsky, Lisa Neff, George A. Bray, Jeffrey Curtis, Robert Nelson, Jennifer Weil, Patrick O'Neil, Sun Kim, Karen Johnson, Vivian Fonseca, Philip Raskin, Erin LeBlanc, Sangeeta Kashyap

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Abstract

OBJECTIVE: Observational studies suggest that vitamin D may lower the risk of type 2 diabetes. However, data from long-term trials are lacking. The Vitamin D and Type 2 Diabetes (D2d) study is a randomized clinical trial designed to examine whether a causal relationship exists between vitamin D supplementation and the development of diabetes in people at high risk for type 2 diabetes. RESEARCH DESIGN AND METHODS: D2d was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The final protocol was approved by the D2d Research Group, the data and safety monitoring board, and NIDDK. Key eligibility criteria are age ≥30 years, BMI of 24 (22.5 for Asian Americans) to 42 kg/m2, increased risk for diabetes (defined as meeting two of three glycemic criteria for prediabetes established by the American Diabetes Association [fasting glucose 100-125 mg/dL (5.5-6.9 mmol/L), 2-h postload glucose after 75-g glucose load 140-199 mg/dL (7.7-11.0 mmol/L), hemoglobin A1c 5.7-6.4% (39-46 mmol/mol)]), and no hyperparathyroidism, nephrolithiasis, or hypercalcemia. D2d participants are randomized to once-daily vitamin D3 (cholecalciferol 4,000 IU) or placebo and followed for an average of 3 years. The primary end point is time to incident diabetes as assessed by laboratory criteria during the study or by adjudication if diagnosed outside of D2d. Recruitment was initiated at the end of 2013. CONCLUSIONS: D2d will test whether vitamin D supplementation is safe and effective at lowering the risk of progression to diabetes in people at high risk for type 2 diabetes.

LanguageEnglish (US)
Pages3227-3234
Number of pages8
JournalDiabetes Care
Volume37
Issue number12
DOIs
StatePublished - Dec 1 2014

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Ergocalciferols
Type 2 Diabetes Mellitus
National Institute of Diabetes and Digestive and Kidney Diseases (U.S.)
Vitamin D
Cholecalciferol
Glucose
Clinical Trials Data Monitoring Committees
Prediabetic State
Nephrolithiasis
Asian Americans
Hyperparathyroidism
Organized Financing
Hypercalcemia
Observational Studies
Fasting
Hemoglobins
Research Design
Randomized Controlled Trials
Placebos

ASJC Scopus subject areas

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

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Rationale and design of the vitamin D and type 2 diabetes (D2d) study : A diabetes prevention trial. / D2d Research Group.

In: Diabetes Care, Vol. 37, No. 12, 01.12.2014, p. 3227-3234.

Research output: Contribution to journalArticle

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abstract = "OBJECTIVE: Observational studies suggest that vitamin D may lower the risk of type 2 diabetes. However, data from long-term trials are lacking. The Vitamin D and Type 2 Diabetes (D2d) study is a randomized clinical trial designed to examine whether a causal relationship exists between vitamin D supplementation and the development of diabetes in people at high risk for type 2 diabetes. RESEARCH DESIGN AND METHODS: D2d was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The final protocol was approved by the D2d Research Group, the data and safety monitoring board, and NIDDK. Key eligibility criteria are age ≥30 years, BMI of 24 (22.5 for Asian Americans) to 42 kg/m2, increased risk for diabetes (defined as meeting two of three glycemic criteria for prediabetes established by the American Diabetes Association [fasting glucose 100-125 mg/dL (5.5-6.9 mmol/L), 2-h postload glucose after 75-g glucose load 140-199 mg/dL (7.7-11.0 mmol/L), hemoglobin A1c 5.7-6.4{\%} (39-46 mmol/mol)]), and no hyperparathyroidism, nephrolithiasis, or hypercalcemia. D2d participants are randomized to once-daily vitamin D3 (cholecalciferol 4,000 IU) or placebo and followed for an average of 3 years. The primary end point is time to incident diabetes as assessed by laboratory criteria during the study or by adjudication if diagnosed outside of D2d. Recruitment was initiated at the end of 2013. CONCLUSIONS: D2d will test whether vitamin D supplementation is safe and effective at lowering the risk of progression to diabetes in people at high risk for type 2 diabetes.",
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AU - Ware, James H.

AU - Knowler, William C.

AU - Staten, Myrlene A.

AU - Tracy, Russell

AU - Lewis, Michael R.

AU - Phillips, Lawrence

AU - Foreyt, John

AU - Chatterjee, Ranee

AU - Pratley, Richard

AU - Chadha, Chhavi

AU - Robbins, David

AU - Peters, Anne

AU - Brodsky, Irwin

AU - Aroda, Vanita

AU - Desouza, Cyrus

AU - Poretsky, Leonid

AU - Neff, Lisa

AU - Bray, George A.

AU - Curtis, Jeffrey

AU - Nelson, Robert

AU - Weil, Jennifer

AU - O'Neil, Patrick

AU - Kim, Sun

AU - Johnson, Karen

AU - Fonseca, Vivian

AU - Raskin, Philip

AU - LeBlanc, Erin

AU - Kashyap, Sangeeta

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N2 - OBJECTIVE: Observational studies suggest that vitamin D may lower the risk of type 2 diabetes. However, data from long-term trials are lacking. The Vitamin D and Type 2 Diabetes (D2d) study is a randomized clinical trial designed to examine whether a causal relationship exists between vitamin D supplementation and the development of diabetes in people at high risk for type 2 diabetes. RESEARCH DESIGN AND METHODS: D2d was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The final protocol was approved by the D2d Research Group, the data and safety monitoring board, and NIDDK. Key eligibility criteria are age ≥30 years, BMI of 24 (22.5 for Asian Americans) to 42 kg/m2, increased risk for diabetes (defined as meeting two of three glycemic criteria for prediabetes established by the American Diabetes Association [fasting glucose 100-125 mg/dL (5.5-6.9 mmol/L), 2-h postload glucose after 75-g glucose load 140-199 mg/dL (7.7-11.0 mmol/L), hemoglobin A1c 5.7-6.4% (39-46 mmol/mol)]), and no hyperparathyroidism, nephrolithiasis, or hypercalcemia. D2d participants are randomized to once-daily vitamin D3 (cholecalciferol 4,000 IU) or placebo and followed for an average of 3 years. The primary end point is time to incident diabetes as assessed by laboratory criteria during the study or by adjudication if diagnosed outside of D2d. Recruitment was initiated at the end of 2013. CONCLUSIONS: D2d will test whether vitamin D supplementation is safe and effective at lowering the risk of progression to diabetes in people at high risk for type 2 diabetes.

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