Calcium, Vitamin D and Metformin to Treat Insulin Resistance in Obese African American Adolescent Females

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.

Conditions

• Insulin Resistance
• Insulin Sensitivity
• Obesity
• Vitamin D Deficiency

Interventions

DRUG

Calcium and Vit D

ergocalciferol (vitamin D2) treatment 50,000 IU orally, weekly for 8 weeks calcium carbonate orally 1200mg daily

DRUG

Metformin, Vit D and Calcium

ergocalciferol (vitamin D2)50,000 IU orally weekly for 8 weeks calcium carbonate orally 1200mg daily Metformin ER 1000mg daily with dinner for 7 days and then increased to a final dose of 2000mg orally, daily for the remainder of the study (7 weeks)

Sponsors & Collaborators

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Stephenie B Wallace · UAB Department of Pediatrics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

19 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2010-09-30

Completion

2011-03-31