Effects of Short-term Growth Hormone in HIV-infected Patients
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ClinicalTrials.gov Identifier: NCT00795210 |
Recruitment Status :
Completed
First Posted : November 21, 2008
Results First Posted : January 8, 2014
Last Update Posted : January 8, 2014
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Sponsor:
Massachusetts General Hospital
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
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Tracking Information | ||||
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First Submitted Date ICMJE | November 20, 2008 | |||
First Posted Date ICMJE | November 21, 2008 | |||
Results First Submitted Date ICMJE | October 9, 2013 | |||
Results First Posted Date ICMJE | January 8, 2014 | |||
Last Update Posted Date | January 8, 2014 | |||
Study Start Date ICMJE | February 2009 | |||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug [ Time Frame: after 2 weeks treatment ] Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.
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Original Primary Outcome Measures ICMJE |
Overnight mean growth hormone secretion [ Time Frame: after 2 weeks treatment and 2 weeks withdrawal ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Insulin Sensitivity [ Time Frame: after two weeks treatment ] insulin-stimulated glucose uptake as measured by euglycemic hyperinsulinemic clamp; "M" value (infusion rate with space correction, using method of DeFronzo) for the steady state between 100-120 minutes of clamp is given
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Original Secondary Outcome Measures ICMJE |
insulin sensitivity [ Time Frame: after two weeks treatment and two weeks withdrawal ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Effects of Short-term Growth Hormone in HIV-infected Patients | |||
Official Title ICMJE | Effects of Short-term Growth Hormone in HIV-infected Patients | |||
Brief Summary | The purpose of this study is to examine the short-term effects of two different doses of growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth hormone administration will alter the body's endogenous pulsatile growth hormone secretion and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to insulin sensitivity. | |||
Detailed Description | The primary objective of this study is to determine the differential effects of growth hormone releasing hormone (GHRH) vs. low dose physiologic growth hormone (GH) vs. higher dose GH treatment and withdrawal on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Subjects with HIV-infection will be randomized to receive one of three treatments: GHRH 2mg/day, or growth hormone 6mcg/kg/day (physiologic "low" dose), or growth hormone 2mg/day ("higher" dose) for 2 weeks. At baseline and after two weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp. Subjects will then stop the treatment and will return for an identical assessment after a 2 week withdrawal period. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HIV Lipodystrophy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
25 | |||
Original Estimated Enrollment ICMJE |
51 | |||
Actual Study Completion Date ICMJE | November 2012 | |||
Actual Primary Completion Date | November 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
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Administrative Information | ||||
NCT Number ICMJE | NCT00795210 | |||
Other Study ID Numbers ICMJE | DK63639A R01DK063639 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Steven K. Grinspoon, MD, Massachusetts General Hospital | |||
Original Responsible Party | Steven Grinspoon, MD, Massachusetts General Hospital | |||
Current Study Sponsor ICMJE | Massachusetts General Hospital | |||
Original Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||
Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||
Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | |||
Verification Date | October 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |