Calcium, Vitamin D and Metformin to Treat Insulin Resistance in Obese African American Adolescent Females
Status:
Withdrawn
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
This is a feasibility study to examine the treatment with Metformin, vitamin D with calcium
supplement for insulin resistance in obese, black, female teens. The association of low
vitamin D levels and decreased insulin sensitivity has been established. Thus, the specific
aims of this study are:
Specific aim 1: To examine the effect of an 8-week treatment with vitamin D and calcium
supplementations on diabetes-related risk factors in obese, black, female teens.
Hypothesis 1a: In obese, black, female teens with both insulin resistance and vitamin D
deficiency, treatment with vitamin D and calcium supplementation will significantly improve
measures of insulin resistance and sensitivity (as determined by the homeostatic model
assessment for insulin resistance and whole body insulin sensitivity index measures) when
compared to controls not receiving vitamin D and calcium.
Hypothesis 1b: In obese, black teen females with both insulin resistance and vitamin D
deficiency, treatment with vitamin D and calcium supplementation will significantly improve
measures of cardiovascular disease (decreased BMI and improved triglycerides and LDL) when
compared to controls not receiving vitamin D and calcium.
Specific aim 2: To determine if the addition of Metformin to the 8-week treatment with
vitamin D and calcium supplementations improves diabetes-related risk factors in obese,
black, female teens.
Hypothesis 2a: In obese, black, female teens with both insulin resistance and vitamin D
deficiency, treatment with Metformin, vitamin D, and calcium supplementation will
significantly improve measures of insulin resistance and sensitivity (as determined by the
homeostatic model assessment for insulin resistance and whole body insulin sensitivity index
measures) when compared to standard of care or treatment with vitamin D with calcium
supplementation alone while controlling for dietary intake of vitamin D and calcium.
Hypothesis 2b: In obese, black, female teens with both insulin resistance and vitamin D
deficiency, treatment with Metformin, vitamin D, and calcium supplementation will
significantly improve measures of cardiovascular disease risk (as determined by the decreased
BMI, improved triglycerides and LDL) when compared to standard of care or treatment with
vitamin D with calcium supplementation alone while controlling for dietary intake of vitamin
D and calcium.