Calcium, Vitamin D and Metformin to Treat Insulin Resistance in Obese African American Adolescent Females
Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insulin Resistance; Insulin Sensitivity; Obesity; Vitamin D Deficiency
Intervention: Calcium and Vit D (Drug); Metformin, Vit D and Calcium (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: University of Alabama at Birmingham Official(s) and/or principal investigator(s): Stephenie B Wallace, Principal Investigator, Affiliation: UAB Department of Pediatrics
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.
Clinical Details
Official title: Calcium, Vitamin D and Metformin to Treat Insulin Resistance in Obese African American Adolescent Females.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The insulin sensitivity indices (HOMA IR)
Secondary outcome: Low-density lipoprotein LDLThe insulin sensitivity indices (WBISI) High density lipoprotein
Detailed 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.
Eligibility
Minimum age: 14 Years.
Maximum age: 19 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: June 2009
Last updated: March 9, 2015
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