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

NCT01107808 | Withdrawn

• 2 other identifiers: UAB MHRC SBWF090213004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Adolescents; African American; Female

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Low-density lipoprotein LDL

  8 week

• The insulin sensitivity indices (WBISI)

  8 weeks

• High density lipoprotein

  8 weeks

Study Arms (3)

Control

NO INTERVENTION

The adolescents randomized to Standard of care group will receive the medical and behavioral counseling regarding their obesity as a patient of the Children's Center for Weight Management (CCWM). They will not receive any pharmacological treatment for their vitamin D deficiency or insulin resistance. Calcium and vitamin D dietary intake will be determined using a specific food frequency questionnaire at each study visit for all groups. This will be used to determine effect of nutrition counseling.

Calcium and Vit D

EXPERIMENTAL

The participants in the vitamin D/calcium group will receive standard of care through the CCWM along with the addition of treatment with ergocalciferol (vitamin D2) and calcium carbonate for their vitamin D deficiency. The vitamin D treatment will be 50,000 IU orally weekly for 8 weeks. This treatment regimen for vitamin D deficiency has been found to be safe to children and adolescents. 32 33The dose of calcium supplementation will be calcium carbonate orally 1200mg daily. This is the daily recommended intake of calcium for adolescents

Drug: Calcium and Vit D

Metformin/ Vit D

EXPERIMENTAL

The participants randomized into the vitamin D/calcium/Metformin treatment group will receive standard of care through the CCWM in addition to treatment for their Vitamin D deficiency with the same doses of ergocalciferol (vitamin D2) and calcium carbonate as previously outlined. Additionally, these participants will receive Metformin ER to treat insulin resistance. The Metformin ER will be started at 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).

Drug: Metformin, Vit D and Calcium

Interventions

Calcium and Vit D DRUG

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

Also known as: Vitamin D2 =ergocalciferol

Calcium and Vit D

Metformin, Vit D and Calcium DRUG

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)

Also known as: Gluophage

Metformin/ Vit D

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• pregnancy
• male
• kidney or liver dysfunction
• unwilling to take pill/medication during the trial interested in becoming pregnant

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Insulin Resistance; Obesity; Vitamin D Deficiency

Interventions

Calcium; Ergocalciferols; Metformin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Stephenie B Wallace

  UAB Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 21, 2010
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 10, 2015

Record last verified: 2011-03