Effects of Growth Hormone Releasing Hormone in HIV
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ClinicalTrials.gov Identifier: NCT01263717 |
Recruitment Status :
Completed
First Posted : December 21, 2010
Results First Posted : October 13, 2014
Last Update Posted : October 30, 2017
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Sponsor:
Massachusetts General Hospital
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 | December 16, 2010 | |||
First Posted Date ICMJE | December 21, 2010 | |||
Results First Submitted Date ICMJE | September 8, 2014 | |||
Results First Posted Date ICMJE | October 13, 2014 | |||
Last Update Posted Date | October 30, 2017 | |||
Study Start Date ICMJE | December 2010 | |||
Actual Primary Completion Date | February 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Effects of Growth Hormone Releasing Hormone in HIV | |||
Official Title ICMJE | Effects of Growth Hormone Releasing Hormone on Fat Redistribution, Cardiovascular Indices, and Growth Hormone Secretion in HIV Lipodystrophy | |||
Brief Summary | HIV-infection and its treatment are often associated with an increase in belly fat, as well as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may contribute independently to increased belly fat and to increased cardiovascular risk through effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet known. The current study is designed to determine the effects of tesamorelin treatment on fat accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers of cardiovascular health including blood vessel thickness (carotid intima media thickness [cIMT]) and markers of inflammation in the body. The investigators hypothesize that tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers of inflammation, with either neutral or beneficial effects on glucose metabolism. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 |
54 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Actual Study Completion Date ICMJE | February 2014 | |||
Actual Primary Completion Date | February 2014 (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 65 Years (Adult, Older 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 | NCT01263717 | |||
Other Study ID Numbers ICMJE | 2007p-000638 | |||
Has Data Monitoring Committee | Yes | |||
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 K. Grinspoon, M.D., Massachusetts General Hospital | |||
Current Study Sponsor ICMJE | Massachusetts General Hospital | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | |||
Verification Date | September 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |