Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men

NCT00309855

Aging

COMPLETED PHASE1

Cycled Testosterone Replacement Study

NCT00957528

Hypogonadism

COMPLETED PHASE1

Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism

NCT02159469

Hypogonadism

COMPLETED PHASE3

Efficacy and Safety of Testosterone Nasal Gel for Treating Hypogonadism in Men.

NCT03281187

Hypogonadism

UNKNOWN PHASE3

Oral Testosterone for the Treatment of Hypogonadism

NCT01717768

Hypogonadism

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Growth Hormone Releasing Hormone

Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily

Group Type EXPERIMENTAL

Growth Hormone Releasing Hormone (Tesamorelin)

Intervention Type DRUG

Tesamorelin 2mg subcutaneous daily x 2 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Growth Hormone Releasing Hormone (Tesamorelin)

Tesamorelin 2mg subcutaneous daily x 2 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tesamorelin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes