DRUG
Growth Hormone Releasing Hormone (Tesamorelin)
Tesamorelin 2mg subcutaneous daily x 2 weeks
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Status
Completed
Phase
Not applicable
Enrollment
15
Locations
1
Results
Posted
Publications
2
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Feb 25, 2009
Study start
Feb 2009
Primary completion
Apr 2010
Study completion
Apr 2010
Results posted
Mar 30, 2011
Registry updated
Apr 19, 2011
Outcomes
What the study measures.
Primary outcomes
Mean Overnight Growth Hormone
Time frame · 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 outcomes
Insulin Stimulated Glucose Utilization
Time frame · 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
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Sex
- MALE
- Healthy volunteers
- Yes
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.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
MGH
Boston, Massachusetts, United States
Publications
Results and literature.
PMID 20943777 ↗Stanley TL, Chen CY, Branch KL, Makimura H, Grinspoon SK. Effects of a growth hormone-releasing hormone analog on endogenous GH pulsatility and insulin sensitivity in healthy men. J Clin Endocrinol Metab. 2011 Jan;96(1):150-8. doi: 10.1210/jc.2010-1587. Epub 2010 Oct 13.PMID 21531600 ↗Makimura H, Stanley TL, Chen CY, Branch KL, Grinspoon SK. Relationship of adiponectin to endogenous GH pulse secretion parameters in response to stimulation with a growth hormone releasing factor. Growth Horm IGF Res. 2011 Jun;21(3):155-9. doi: 10.1016/j.ghir.2011.03.009. Epub 2011 Apr 30.
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