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Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00850564
First received: February 23, 2009
Last updated: April 15, 2011
Last verified: April 2011
History of Changes
Results First Received: March 3, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy Volunteers
Intervention: Drug: Growth Hormone Releasing Hormone (Tesamorelin)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
recruitment from March 2009 through March 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Growth Hormone Releasing Hormone (Tesamorelin) Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily

Participant Flow:   Overall Study
    Growth Hormone Releasing Hormone (Tesamorelin)  
STARTED     15  
COMPLETED     13  
NOT COMPLETED     2  
Withdrawal by Subject                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Growth Hormone Releasing Hormone (Tesamorelin) Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily

Baseline Measures
    Growth Hormone Releasing Hormone (Tesamorelin)  
Number of Participants  
[units: participants]
 		  15  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  44  ± 13  
Gender  
[units: participants]
 		 
Female     0  
Male     15  
Region of Enrollment  
[units: participants]
 		 
United States     15  



  Outcome Measures
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1.  Primary:   Mean Overnight Growth Hormone   [ Time Frame: at 2 weeks (i.e., after 2 weeks of treatment) ]
  Show Outcome Measure 1

2.  Secondary:   Insulin Stimulated Glucose Utilization   [ Time Frame: at 2 weeks (i.e., after 2 weeks of treatment) ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Steven Grinspoon, MD
Organization: Massachusetts General Hospital
phone: 617-724-9109
e-mail: sgrinspoon@partners.org


Publications of Results:

Publications automatically indexed to this study:


Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00850564     History of Changes
Other Study ID Numbers: DK63639B, R01DK063639
Study First Received: February 23, 2009
Results First Received: March 3, 2011
Last Updated: April 15, 2011
Health Authority: United States: Food and Drug Administration