Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Growth Hormone Releasing Hormone (Tesamorelin) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Steven K Grinspoon, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital
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.
Clinical Details
Official title: Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean Overnight Growth Hormone
Secondary outcome: Insulin Stimulated Glucose Utilization
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Male.
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.
Locations and Contacts
MGH, Boston, Massachusetts 02114, United States
Additional Information
Starting date: February 2009
Last updated: April 15, 2011
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