Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00850564
First received: February 23, 2009
Last updated: April 15, 2011
Last verified: April 2011

February 23, 2009
April 15, 2011
February 2009
April 2010   (final data collection date for primary outcome measure)
Mean Overnight Growth Hormone [ Time Frame: at 2 weeks (i.e., after 2 weeks of treatment) ] [ Designated as safety issue: No ]
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.
Mean overnight growth hormone [ Time Frame: after 2 weeks of treatment then 2 weeks of withdrawal ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00850564 on ClinicalTrials.gov Archive Site
Insulin Stimulated Glucose Utilization [ Time Frame: at 2 weeks (i.e., after 2 weeks of treatment) ] [ Designated as safety issue: No ]
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.
Insulin stimulated glucose utilization [ Time Frame: after 2 weeks of treatment then 2 weeks of withdrawal ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
Drug: Growth Hormone Releasing Hormone (Tesamorelin)
Tesamorelin 2mg subcutaneous daily x 2 weeks
Other Name: Tesamorelin
Experimental: Growth Hormone Releasing Hormone
Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
Intervention: Drug: Growth Hormone Releasing Hormone (Tesamorelin)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Male
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00850564
DK63639B, R01DK063639
No
Steven K. Grinspoon, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Steven K Grinspoon, M.D. Massachusetts General Hospital
Massachusetts General Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP