Growth Hormone Treatment on Phosphocreatine Recovery in Obesity
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effects of Short Term Growth Hormone Treatment on Skeletal Muscle Phosphocreatine Recovery in Obesity|
- Change in Phosphocreatine recovery [ Time Frame: Baseline and 12-weeks ] [ Designated as safety issue: No ]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.
- Change in skeletal muscle mitochondrial gene expression [ Time Frame: Baseline and 12-weeks ] [ Designated as safety issue: No ]
- Change in intramyocellular lipid content [ Time Frame: Baseline and 12-weeks ] [ Designated as safety issue: No ]
- Change in body composition [ Time Frame: Baseline and 12-weeks ] [ Designated as safety issue: No ]
- Change in lipid profile [ Time Frame: Baseline and 12-weeks ] [ Designated as safety issue: No ]
- Change in insulin sensitivity [ Time Frame: Baseline and 12-weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Experimental: Growth Hormone||
Drug: Growth hormone treatment
Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Hideo Makimura, MD, PhD||Massachusetts General Hospital|