Low Dose Growth Hormone Treatment in Subjects With Metabolic Syndrome.
Low dose growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of subjects with metabolic syndrome.
The purpose of this study is to determine the mechanism of how low dose GH treatment affects the body's sensitivity to insulin actions and whether this low GH dose can affect the body's handling of steroid hormone levels (cortisol clearance) and fat deposition in subjects with metabolic syndrome.
Study design: Subjects that satisfy the criteria of metabolic syndrome (central obesity, treated or untreated high blood pressure, high cholesterol and impaired fasting glucose levels) will be invited to participate in this study. The subjects will be assessed at the initial visit to ascertain their suitability before further participation in the study. If eligible, an equal number of men and women will be randomized (like a flip of a coin) to receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging over for another 12 weeks of treatment after a 4-week washout period. Before, during and after treatment, the subjects will be assessed at frequently with blood tests, scans and fat biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and Translational Research Institute (OCTRI). At the first, second and final visit, testing will include scans to measure the amount of whole body fat and fat in the stomach area, muscle, and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy) analysis to measure the density of insulin-like growth factor-I (a hormone stimulated by growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in the body (insulin sensitivity) will be collected at all visits of the study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of a Fixed Low Dose Growth Hormone Therapy on Insulin Sensitivity, Metabolic Profile, Adipocyte IGF-I and Insulin Signalling, Intramyocellular and Intrahepatic Lipids, and Cortisol Metabolism in Subjects With Metabolic Syndrome.|
- Changes in insulin sensitivity, and adipocyte IGF-I and insulin receptor signaling. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Changes in body composition, cortisol production rates, and muscle and liver intramyocellular content. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Growth hormone or Placebo 0.1 mg/day self-administrated once a day.
Norditropin 0.1 mg/day self-administered once a day subcutaneously
Other Name: Growth hormone, metabolic syndrome, insulin sensitivity
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00720616
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Kevin C. Yuen, MRCP(UK), MD||Oregon Health and Science University|