Vitamin D and Type 2 Diabetes Study
Trial ID or NCT#
NCT01942694
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 30 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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/m24. 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 diabetes2. 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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Melanie Rosenberg
650-485-3910
View on ClinicalTrials.gov
