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Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

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ClinicalTrials.gov Identifier: NCT00850564
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : March 30, 2011
Last Update Posted : April 19, 2011
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy Volunteers
Intervention Drug: Growth Hormone Releasing Hormone (Tesamorelin)
Enrollment 15
Recruitment Details recruitment from March 2009 through March 2010
Pre-assignment Details  
Arm/Group Title Growth Hormone Releasing Hormone (Tesamorelin)
Hide Arm/Group Description Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Period Title: Overall Study
Started 15
Completed 13
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Growth Hormone Releasing Hormone (Tesamorelin)
Hide Arm/Group Description Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
44  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
0
   0.0%
Male
15
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Mean Overnight Growth Hormone
Hide Description 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.
Time Frame at 2 weeks (i.e., after 2 weeks of treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
analysis of 13 participants who completed both baseline and 2 week visits
Arm/Group Title Growth Hormone Releasing Hormone (Tesamorelin)
Hide Arm/Group Description:
Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Overall Number of Participants Analyzed 13
Mean (Standard Error)
Unit of Measure: mcg/L
1.2  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Growth Hormone Releasing Hormone (Tesamorelin)
Comments Paired t-test comparing baseline and 2 week mean overnight growth hormone
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
2.Secondary Outcome
Title Insulin Stimulated Glucose Utilization
Hide Description 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.
Time Frame at 2 weeks (i.e., after 2 weeks of treatment)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Releasing Hormone (Tesamorelin)
Hide Arm/Group Description:
Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Overall Number of Participants Analyzed 13
Mean (Standard Error)
Unit of Measure: mg/kg/min
7.5  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Growth Hormone Releasing Hormone (Tesamorelin)
Comments Paired t-test comparing insulin stimulated glucose uptake (M) between baseline and 2 week visits.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Time Frame Total of 4 weeks: 2 weeks of treatment with study drug, followed by 2 weeks off drug
Adverse Event Reporting Description Subjects queried about potential side effects at 2 week visit (after 2 weeks on study drug) and at 4 week visit (after 2 weeks off drug)
 
Arm/Group Title Growth Hormone Releasing Hormone (Tesamorelin)
Hide Arm/Group Description Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
All-Cause Mortality
Growth Hormone Releasing Hormone (Tesamorelin)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Growth Hormone Releasing Hormone (Tesamorelin)
Affected / at Risk (%) # Events
Total   1/13 (7.69%)    
Infections and infestations   
Influenza due to Influenza A virus  1 [1]  1/13 (7.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, SNOMED CT
[1]
Influenza infection requiring hospitalization
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Growth Hormone Releasing Hormone (Tesamorelin)
Affected / at Risk (%) # Events
Total   4/13 (30.77%)    
Cardiac disorders   
chest pain  1 [1]  1/13 (7.69%)  1
Gastrointestinal disorders   
Diarrhea  1 [2]  1/13 (7.69%)  2
Nervous system disorders   
Headache  1 [3]  1/13 (7.69%)  2
Dizziness  1 [4]  1/13 (7.69%)  1
Skin and subcutaneous tissue disorders   
rash  1 [5]  1/13 (7.69%)  1
Complaining of itching  1 [6]  1/13 (7.69%)  1
Burn of back  1  1/13 (7.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, SNOMED CT
[1]
mild chest pain - EKG, cardiac enzymes, stress test all normal.
[2]
2 episodes of watery diarrhea, self-resolved
[3]
2 mild headaches, self-resolved
[4]
mild dizziness some mornings while on study medication, resolved on discontinuation
[5]
mild rash on dorsum of hands, self-resolved
[6]
itching and mild swelling around site of intravenous (IV) catheter, self-resolved
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.
Results Point of Contact
Name/Title: Steven Grinspoon, MD
Organization: Massachusetts General Hospital
Phone: 617-724-9109
Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00850564     History of Changes
Other Study ID Numbers: DK63639B
R01DK063639 ( U.S. NIH Grant/Contract )
First Submitted: February 23, 2009
First Posted: February 25, 2009
Results First Submitted: March 3, 2011
Results First Posted: March 30, 2011
Last Update Posted: April 19, 2011