Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Growth Hormone Releasing Hormone Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily |
Drug: Growth Hormone Releasing Hormone (Tesamorelin)
Tesamorelin 2mg subcutaneous daily x 2 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Overnight Growth Hormone [at 2 weeks (i.e., after 2 weeks of treatment)]
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.
Secondary Outcome Measures
- Insulin Stimulated Glucose Utilization [at 2 weeks (i.e., after 2 weeks of treatment)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men aged 18-60 years
-
BMI > 20kg/m2 and <35kg/m2
Exclusion Criteria:
-
Use of anti-diabetic agents, Megace, testosterone or any steroid use within 6 months of the study
-
Use of GH or growth hormone stimulating peptides within six months of starting the study
-
Change in lipid lowering or antihypertensive regimen within 3 months of screening
-
Fasting blood sugar > 126 mg/dL, SGOT > 2.5 times ULN, Hgb < 12.0 g/dL, creatinine > 1.4 mg/dL
-
Carpal tunnel syndrome
-
Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
-
For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5 ng/mL
-
Prior history of hypopituitarism, head irradiation or any other condition known to affect the GH axis
-
Weight < 110 lbs.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MGH | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Steven K Grinspoon, M.D., Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DK63639B
- R01DK063639
Study Results
Participant Flow
| Recruitment Details | recruitment from March 2009 through March 2010 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Growth Hormone Releasing Hormone (Tesamorelin) |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Growth Hormone Releasing Hormone (Tesamorelin) |
|---|---|
| Arm/Group Description | Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily |
| Overall Participants | 15 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
15
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
44
(13)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
15
100%
|
| Region of Enrollment (participants) [Number] | |
| United States |
15
100%
|
Outcome Measures
| Title | Mean Overnight Growth Hormone |
|---|---|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| analysis of 13 participants who completed both baseline and 2 week visits |
| Arm/Group Title | Growth Hormone Releasing Hormone (Tesamorelin) |
|---|---|
| Arm/Group Description | Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily |
| Measure Participants | 13 |
| Mean (Standard Error) [mcg/L] |
1.2
(0.3)
|
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 | ||
| Statistical Test of Hypothesis | p-Value | <0.005 |
| Comments | ||
| Method | Paired t-test | |
| Comments | ||
| Title | Insulin Stimulated Glucose Utilization |
|---|---|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Growth Hormone Releasing Hormone (Tesamorelin) |
|---|---|
| Arm/Group Description | Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily |
| Measure Participants | 13 |
| Mean (Standard Error) [mg/kg/min] |
7.5
(1.2)
|
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 | ||
| Statistical Test of Hypothesis | p-Value | 0.61 |
| Comments | ||
| Method | Paired t-test | |
| Comments | ||
Adverse Events
| 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) | |
| 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 (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Growth Hormone Releasing Hormone (Tesamorelin) | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/13 (7.7%) | |
| Infections and infestations | ||
| Influenza due to Influenza A virus | 1/13 (7.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Growth Hormone Releasing Hormone (Tesamorelin) | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/13 (30.8%) | |
| Cardiac disorders | ||
| chest pain | 1/13 (7.7%) | 1 |
| Gastrointestinal disorders | ||
| Diarrhea | 1/13 (7.7%) | 2 |
| Nervous system disorders | ||
| Headache | 1/13 (7.7%) | 2 |
| Dizziness | 1/13 (7.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| rash | 1/13 (7.7%) | 1 |
| Complaining of itching | 1/13 (7.7%) | 1 |
| Burn of back | 1/13 (7.7%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Steven Grinspoon, MD |
|---|---|
| Organization | Massachusetts General Hospital |
| Phone | 617-724-9109 |
| sgrinspoon@partners.org |
- DK63639B
- R01DK063639