Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

Healthy Volunteers Clinical Trial

Official title:

Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850564
• Other study ID #: DK63639B
• Secondary ID: R01DK063639
• Status: Completed
• Phase: N/A
• First received: February 23, 2009
• Last updated: April 15, 2011
• Start date: February 2009
• Est. completion date: April 2010

Study information

• Verified date: April 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Growth Hormone Releasing Hormone (Tesamorelin)
Tesamorelin 2mg subcutaneous daily x 2 weeks

Locations

Country	Name	City	State
United States	MGH	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stanley TL, Chen CY, Branch KL, Makimura H, Grinspoon SK. Effects of a growth hormone-releasing hormone analog on endogenous GH pulsatility and insulin sensitivity in healthy men. J Clin Endocrinol Metab. 2011 Jan;96(1):150-8. doi: 10.1210/jc.2010-1587. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No