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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


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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Male.


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


- 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


- 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

Page last updated: August 23, 2015

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