Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

This study is currently recruiting participants.

Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), August 2009

First Received: February 23, 2009 Last Updated: August 6, 2009 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00850564

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:	Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

Resource links provided by NLM:

Drug Information available for: Somatropin Somatorelin Sermorelin Sermorelin acetate Tesamorelin Somatotropin

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Mean overnight growth hormone [ Time Frame: after 2 weeks of treatment then 2 weeks of withdrawal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Insulin stimulated glucose utilization [ Time Frame: after 2 weeks of treatment then 2 weeks of withdrawal ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Growth Hormone Releasing Hormone (Tesamorelin)	Drug: Growth Hormone Releasing Hormone (Tesamorelin) Tesamorelin 2mg subcutaneous daily x 2 weeks

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

Contacts

Contact: Takara L Stanley, M.D.

617-726-5312

tstanley@parnters.org

Locations

United States, Massachusetts
MGH	Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Steven K Grinspoon, M.D.

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Steven K Grinspoon, M.D.

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( Steven K. Grinspoon, MD )
Study ID Numbers:	DK63939B
Study First Received:	February 23, 2009
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00850564 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

growth hormone releasing hormone

Additional relevant MeSH terms:

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Growth Hormone-Releasing Hormone
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010