Status:
COMPLETED
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-60 years
Phase:
NA
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 he...
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-s...
Eligibility Criteria
Inclusion
- Men aged 18-60 years
- BMI \> 20kg/m2 and \<35kg/m2
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00850564
Start Date
February 1 2009
End Date
April 1 2010
Last Update
April 19 2011
Active Locations (1)
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1
MGH
Boston, Massachusetts, United States, 02114