Clinical trial NCT00850564: Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Official title: Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: growth hormone releasing hormone
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-02-25
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Mean Overnight Growth Hormone
timeFrame: at 2 weeks (i.e., after 2 weeks of treatment)
Secondary outcomes:
measure: Insulin Stimulated Glucose Utilization
timeFrame: at 2 weeks (i.e., after 2 weeks of treatment)
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven K Grinspoon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1210/jc.2010-1587. Epub 2010 Oct 13.
citation: 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. doi: 10.1016/j.ghir.2011.03.009. Epub 2011 Apr 30.