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Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men - NCT00850564-02114(Clinical Trial 274472)



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City:  Boston
State:  
MA
Zip Code: 02114
Conditions: Healthy Volunteers
Purpose: 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.
Study summary: 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.
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.
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Data Source: ClinicalTrials.gov
Date Processed: September 22, 2010
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