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Poor recruitment to the study
Sponsor study identifier
Secondary identifiers
OTHER · UAB IRB
interventional
0
0 countries
N/A
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
April 1, 2010
Actual (reported)April 21, 2010
Actual (reported)September 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Low-density lipoprotein LDL
8 week
The insulin sensitivity indices (WBISI)
8 weeks
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.
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
ergocalciferol (vitamin D2) treatment 50,000 IU orally, weekly for 8 weeks calcium carbonate orally 1200mg daily
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)
Stephenie B Wallace
UAB Department of Pediatrics
0 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2010
First Posted
April 21, 2010
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
High density lipoprotein
8 weeks
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).
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Primary Completion
September 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 10, 2015
Record last verified: 2011-03
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Source: ClinicalTrials.gov.
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