Type 2 Diabetes
Conditions
Keywords
vitamin D status, 25-OH D, ionized calcium, fasting glucose, hemoglobin A1c, fasting insulin, glucose metabolism, HOMA index, blood lipids, type 2 diabetes, PTH, adiposity, body fat percentage, dual energy x-ray absorptiometry, pulse wave velocity, arterial stiffness, flow-mediated dilation, African American, inflammatory markers
Brief summary
Type 2 diabetes is more common among African Americans than Caucasians. African Americans are also at a higher risk for lower levels of vitamin D compared to other ethnic groups. The investigators don't yet know if there is a connection between not having enough vitamin D and type 2 diabetes in African Americans. Researchers have found that the less vitamin D Caucasians had the higher the chance they would have type 2 diabetes but it is less clear if this is the case for African Americans. The investigators want to better understand how vitamin D status and diabetes risk are linked in African Americans. Also, the investigators want to see if supplementation with vitamin D will improve your blood pressure, blood sugar, & insulin. All of these are in some way related to diabetes. The investigators want to measure changes in blood sugar & blood pressure in people who do not have diabetes with the hope of learning new information to help treat those that do have diabetes. The investigators hypothesize that vitamin D status is related to diabetes risk measured by hemoglobin A1c (a test of glucose level over time), fasting glucose and insulin in non-diabetic African American adults and that body weight status may affect vitamin D status in response to vitamin D supplements compared to placebo.
Detailed description
Participants will be randomly assigned to receive either a 60,000 IU vitamin D3 supplement every four weeks or an inactive placebo. All investigators and the participants will be blinded to the assignment group of each participant until all testing is completed.
Interventions
1 gelcap of 50,000 IU vitamin D3 plus 2 gelcaps of 5,000 IU vitamin D3 each; a total of 60,000 IU vitamin D3 dosed four weeks apart at weeks 0, 4, 8, and 12 of the 16 week study.
The inactive comparator dose provided was identical in appearance to the active comparator but contained no vitamin D3
Sponsors
Study design
Eligibility
Inclusion criteria
* African American by self-report * In good health
Exclusion criteria
* Diagnosis of diabetes * Health problems/medication affecting calcium and/or vitamin D metabolism * Current use of vitamin/mineral/herbal/nutritional supplements * Inability to swallow pills * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting glucose level before, mid-way through, and after the vitamin D3 supplement or placebo trial. | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Serum 25-OH D levels in response to vitamin D3 supplement or placebo across a range of adiposity | 16 weeks |
Countries
United States