Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	Massachusetts General Hospital
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:	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:

MedlinePlus related topics: Diabetes Medicines

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

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:

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. Epub 2010 Oct 13.

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

Makimura H, Stanley TL, Chen CY, Branch KL, Grinspoon SK. Relationship of adiponectin to endogenous GH pulse secretion parameters in response to stimulation with a growth hormone releasing factor. Growth Horm IGF Res. 2011 Jun;21(3):155-9. Epub 2011 Apr 30.

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 February 09, 2012