NCT01421589|CompletedResultsDMC
Growth Hormone Treatment on Phosphocreatine Recovery in Obesity
The Effects of Short Term Growth Hormone Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity
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Sponsor study identifier
interventional
15
1 country
1
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2013
Actual (reported)Study Completion
March 2013
Actual (reported)Obesity is associated with reduced growth hormone (GH) secretion. Reduced GH secretion in obesity is associated with increased cardiovascular disease risk. However, it is not yet known how reduced GH increases cardiovascular disease risk in obesity. The investigators hypothesize that reduced GH contributes to dysfunction of the mitochondria. Therefore, the investigators hypothesize that treatment of obese subjects with reduced GH secretion with GH will improve mitochondrial function and that this improvement in mitochondrial function will contribute, in part, to the effects of GH to improve metabolic parameters in obesity. The investigators propose to study skeletal muscle mitochondria in obese subjects with reduced GH secretion using magnetic resonance spectroscopy and muscle biopsies before and after treatment with GH.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 19, 2011
Actual (reported)August 23, 2011
Actual (reported)September 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 2013
Actual (reported)March 2013
Actual (reported)July 1, 2014
Actual (reported)Phosphocreatine Recovery
The primary objective of this study is to determine the effects of growth hormone on mitochondrial function as assessed by 31P-MRS in obese subjects with reduced GH secretion. Mitochondrial function was represented by ViPCr, a measure of phosphocreatine recovery after sub-maximal exercise. Univariate regression analyses was performed to assess the relationship between the change in skeletal muscle IGF-1 mRNA after 12 weeks treatment with rhGH to change in ViPCr.
12-weeks
Change in Circulating IGF-1 Concentration
Baseline and 12-weeks
Change in Skeletal Muscle IGF-1 Gene Expression
Baseline and 12-weeks
Change in Body Composition
Baseline and 12-weeks
Change in Inflammatory Marker
Baseline and 12-weeks
Change in Insulin Sensitivity
Baseline and 12-weeks
Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Hideo Makimura, MD, PhD
Massachusetts General Hospital
15 participants (actual enrollment reported by the registry).
First Submitted
August 19, 2011
First Posted
August 23, 2011
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2013
Actual (reported)Study Completion
March 2013
Actual (reported)Last Updated
July 1, 2014
Results First Posted
July 1, 2014
Record last verified: 2014-05
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Source: ClinicalTrials.gov.
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