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Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00850564
First received: February 23, 2009
Last updated: April 15, 2011
Last verified: April 2011
History of Changes
  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.


Condition Intervention
Healthy Volunteers
 Drug: Growth Hormone Releasing Hormone (Tesamorelin)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 15
Study Start Date: February 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Growth Hormone Releasing Hormone
Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
 Drug: Growth Hormone Releasing Hormone (Tesamorelin)
Tesamorelin 2mg subcutaneous daily x 2 weeks
Other Name: Tesamorelin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850564

Locations
United States, Massachusetts
MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Steven K Grinspoon, M.D. Massachusetts General Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00850564     History of Changes
Other Study ID Numbers: DK63639B, R01DK063639
Study First Received: February 23, 2009
Results First Received: March 3, 2011
Last Updated: April 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
growth hormone releasing hormone

Additional relevant MeSH terms:
Hormones
Growth Hormone-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013