Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

April 15, 2011 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Tesamorelin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (ESTIMATE)

February 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 19, 2011

Last Update Submitted That Met QC Criteria

April 15, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK63639B
  • R01DK063639 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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