Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Growth Hormone Releasing Hormone (Tesamorelin)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth Hormone Releasing Hormone<br>Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily | Drug: Growth Hormone Releasing Hormone (Tesamorelin)<br>* Tesamorelin 2mg subcutaneous daily x 2 weeks<br>* Other names: Tesamorelin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Overnight Growth Hormone | 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. | at 2 weeks (i.e., after 2 weeks of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Stimulated Glucose Utilization | 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. | at 2 weeks (i.e., after 2 weeks of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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growth hormone releasing hormone