Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00850564
First received: February 23, 2009
Last updated: April 15, 2011
Last verified: April 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 23, 2009 | ||||
| Last Updated Date | April 15, 2011 | ||||
| Start Date ICMJE | February 2009 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mean Overnight Growth Hormone [ Time Frame: at 2 weeks (i.e., after 2 weeks of treatment) ] [ Designated as safety issue: No ] Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment. |
||||
| Original Primary Outcome Measures ICMJE |
Mean overnight growth hormone [ Time Frame: after 2 weeks of treatment then 2 weeks of withdrawal ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00850564 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Insulin Stimulated Glucose Utilization [ Time Frame: at 2 weeks (i.e., after 2 weeks of treatment) ] [ Designated as safety issue: No ] Insulin stimulated glucose uptake (M) is the amount of glucose (measured in mg per kg body weight per minute) taken up during the steady state period of a euglycemic hyperinsulinemic clamp. This measure was calculated for minutes 100-120 of euglycemic hyperinsulinemic clamp procedure at 2 weeks (i.e., after 2 weeks treatment with growth hormone releasing hormone). The measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the measurement before treatment. |
||||
| Original Secondary Outcome Measures ICMJE |
Insulin stimulated glucose utilization [ Time Frame: after 2 weeks of treatment then 2 weeks of withdrawal ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men | ||||
| Official Title ICMJE | Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men | ||||
| Brief Summary | The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will increase GH pulse height and will not affect insulin sensitivity. |
||||
| Detailed Description | The primary objective of this study is to determine the effects of growth hormone releasing hormone (Tesamorelin) on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Healthy male subjects will receive 2mg Tesamorelin, subcutaneously, daily for two 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 Tesamorelin and will return for an identical assessment after a 2 week withdrawal period. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Healthy Volunteers | ||||
| Intervention ICMJE | Drug: Growth Hormone Releasing Hormone (Tesamorelin)
Tesamorelin 2mg subcutaneous daily x 2 weeks
Other Name: Tesamorelin |
||||
| Study Arm (s) | Experimental: Growth Hormone Releasing Hormone
Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Intervention: Drug: Growth Hormone Releasing Hormone (Tesamorelin) |
||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 15 | ||||
| Completion Date | April 2010 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Male | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00850564 | ||||
| Other Study ID Numbers ICMJE | DK63639B, R01DK063639 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Steven K. Grinspoon, MD, Massachusetts General Hospital | ||||
| Study Sponsor ICMJE | Massachusetts General Hospital | ||||
| Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | April 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||