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Tesamorelin

Egrifta, TH9507

Quick Stats
Studies 64
Trials 24
Completed NA INTERVENTIONAL NCT00795210

Effects of Short-term Growth Hormone in HIV-infected Patients

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this study is to examine the short-term effects of two different doses of growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth hormone administration will alter the body's endogenous pulsatile growth hormone secretion and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to insulin sensitivity.

Detailed Description

The primary objective of this study is to determine the differential effects of growth hormone releasing hormone (GHRH) vs. low dose physiologic growth hormone (GH) vs. higher dose GH treatment and withdrawal on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Subjects with HIV-infection will be randomized to receive one of three treatments: GHRH 2mg/day, or growth hormone 6mcg/kg/day (physiologic "low" dose), or growth hormone 2mg/day ("higher" dose) for 2 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 treatment and will return for an identical assessment after a 2 week withdrawal period.

Interventions

Name: Growth hormone
Type: DRUG
Description: Recombinant Human Growth Hormone (Teva pharmaceuticals), with one arm receiving 6mcg/kg SC once daily for two weeks and the other arm receiving 2mg SC once daily for two weeks
Name: Growth Hormone Releasing Hormone
Type: DRUG
Description: Tesamorelin (GHRH) 2mg SC QD x 2 weeks

Primary Outcomes

Measure: Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug
TimeFrame: after 2 weeks treatment
Description: Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.

Trial Information

NCT ID

NCT00795210

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Massachusetts General Hospital

Last Updated

December 15, 2025

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