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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01107808
Other study ID # UAB MHRC SBW
Secondary ID F090213004
Status Withdrawn
Phase N/A
First received April 1, 2010
Last updated March 9, 2015
Start date June 2009
Est. completion date March 2011

Study information

Verified date March 2011
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

The increasing rate of obesity in youth has reached epidemic proportion in the United States. African Americans share an overwhelming burden of this disorder and its complications.1 Vitamin D deficiency is prevalent in black girls and women2 and is associated with insulin resistance in populations at risk for diabetes.3 The use of Metformin, an oral diabetic agent, to halt the progression to diabetes in individuals at risk has been studied, but not in a population with concurrent vitamin D deficiency. In this proposal, we hypothesize that treatment with vitamin D with calcium supplement along with Metformin together will improve insulin resistance in obese, black teen girls. We will investigate this hypothesis in two specific aims to: 1) examine the effect of treatment of Vitamin D deficiency on insulin resistance in mature black teen girls, 2) to determine if there is any additional benefit of Metformin with treatment for Vitamin D deficiency to improve insulin resistance in this group. We propose to accomplish these aims through a clinical trial in obese black teen girls who have reached developmental maturity (approximately 15-18 years old) with vitamin D deficiency. Eligible participants will be randomized to one of three groups: standard of care, treatment with vitamin D/calcium supplement, and treatment with Vitamin D/Calcium Supplement and Metformin. We will enroll 30 obese adolescent subjects, (10 participants per group) into this 2-month study. The following measurements will be performed at baseline and 2 month follow-up: a) 25-hydroxy-vitamin D, b) Oral glucose tolerance tests to calculate homeostatic model assessment for insulin resistance (HOMA IR), and 4 to determine insulin resistance and total body insulin sensitivity index (TBISI) to determine insulin sensitivity,5 c) body mass index calculations, and c) lipid panel to include triglyceride, HDL-C, and LDL-C measurements. We will control for the effect of nutritional counseling on vitamin D and calcium intake will be controlled. Our outcome measures will include improvement in insulin resistance and decreased body mass index for our participants treated with vitamin D, calcium supplementation and Metformin. Validation of our hypothesis will show that Metformin along with vitamin D treatment and calcium supplementation is a novel treatment combination to improve insulin resistance, the health of an at-risk adolescent population.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2011
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 19 Years
Eligibility Inclusion Criteria:

- 14-19 years old

- female

- african american

- obese

- risk of insulin resistance (physical exam or family history of diabetes

- willing to be randomized to a arm that would take medication

Exclusion Criteria:

- pregnancy

- male

- kidney or liver dysfunction

- unwilling to take pill/medication during the trial interested in becoming pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Calcium and Vit D
ergocalciferol (vitamin D2) treatment 50,000 IU orally, weekly for 8 weeks calcium carbonate orally 1200mg daily
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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Outcome

Type Measure Description Time frame Safety issue
Primary The insulin sensitivity indices (HOMA IR) the HOMA IR will be calculated from glucose and insulin measurements from the OGTT done at the screening and final study visits. 8 weeks No
Secondary Low-density lipoprotein LDL LDL-C will be measured by standard laboratory methods through the hospital clinic lab.The screening and final measurement will be compared for each participant. 8 week No
Secondary The insulin sensitivity indices (WBISI) the WBISI will be calculated from glucose and insulin measurements from the OGTT done at the screening and final study visits. 8 weeks No
Secondary High density lipoprotein HDL will be measured by standard laboratory methods through the hospital clinic lab. The screening and final measurement will be compared for each participant. 8 weeks No
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