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Vitamin D and Type 2 Diabetes Study
Not Recruiting
Trial ID: NCT01942694
Purpose
The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin D affects glucose (sugar) metabolism.
Official Title
Vitamin D and Type 2 Diabetes Study
Stanford Investigator(s)
Sun Kim, M.D. M.S.
Associate Professor of Medicine (Endocrinology)
Eligibility
Inclusion Criteria:
1. Pre-diabetes ("at increased risk for diabetes") defined by meeting 2-out-of-3 of the following glycemic criteria at the baseline visit:
1. Fasting plasma glucose (FPG) 100-125 mg/dL
2. 2-hour plasma glucose (2hPG) 140-199 mg/dL
3. Hemoglobin A1c (HbA1c) 5.7-6.4%
2. Age ≥ 30 years .(≥25 years for people of the following races: American-Indian, Alaska Native, Native Hawaiian or Other Pacific Islander).
3. Body Mass Index ≥ 24.0 (22.5 for Asians) and ≤ 42.0 kg/m2
4. Provision of signed and dated written informed consent prior to any study procedures.
Major Exclusion Criteria:
1. Diabetes based on either of the following criteria:
1. History (past 1 year) of hypoglycemic pharmacotherapy (oral or injectable medication approved by the FDA for type 2 diabetes), used for any condition (e.g. pre-diabetes, diabetes, polycystic ovarian syndrome.
2. Meeting the diagnosis criteria for diabetes
2. History (past 3 years) of hyperparathyroidism, nephrolithiasis or hypercalcemia.
3. Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to become pregnant in the next 4 years or unprotected intercourse. History of gestational diabetes is not an exclusion criterion.
4. Currently breastfeeding.
Intervention(s):
other: Placebo
dietary_supplement: Vitamin D (Cholecalciferol)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Melanie Rosenberg
650-485-3910