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Mod GRF 1-29

Sermorelin, Growth Hormone Releasing Hormone (1-29), hGRF(1-29)NH2

Quick Stats
Studies 227
Trials 47
Terminated PHASE4 INTERVENTIONAL NCT00720902

Adult Growth Hormone Deficiency and Cardiovascular Risk

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize that adults with growth hormone deficiency will have results suggestive of an increased risk for cardiovascular disease.

Detailed Description

Subjects will first be tested for possible growth hormone deficiency. This will be done by administering two intravenous medications that should stimulate growth hormone secretion and we will measure growth hormone in the blood every 30 minutes following the administration. Once we have the results on enough subjects we will split the cohort into those subjects who are growth hormone deficient and those who have normal growth hormone. The two groups will each undergo various tests all designed to assess some component of cardiovascular risk. Ultimately we will compare the results of each test to see if those who are growth hormone deficient have an increased risk for cardiovascular disease.

Interventions

Name: Blood draws
Type: PROCEDURE
Description: Subjects will have serum cardiovascular markers assessed
Name: growth hormone releasing hormone (GHRH) & arginine
Type: DRUG
Description: Subjects will receive GHRH and arginine intravenously and then have blood drawn at frequent intervals over a 90 minutes to assess growth hormone secretion.
Name: Carotid ultrasound
Type: PROCEDURE
Description: Subjects will have an ultrasound of their neck to assess their carotid arteries to look for intima-medial thickness.
Name: MRI
Type: PROCEDURE
Description: Subjects will have MRI and MR spectroscopy of the abdomen and lower extremities to assess for fat in internal organs and muscle.
Name: Endothelial cell biopsy
Type: PROCEDURE
Description: Subjects will undergo endothelial cell biopsies to harvest endothelial cells to study. It will occur once and takes approximately 20 minutes. Patients will have an iv placed and then a sterile wire is passed back and forth in the iv a couple of times. Three wires are passed.

Primary Outcomes

Measure: C-reactive Protein (CRP) Levels
TimeFrame: Day 1
Description: C-reactive protein (CRP) levels in GH sufficient and GH deficient participants
Measure: Homocysteine Level
TimeFrame: Day 1
Description: Homocytsteine levels in GH sufficient and GH deficient participants
Measure: Total Cholesterol Level
TimeFrame: Day 1
Description: Total cholesterol levels in GH sufficient and GH deficient participants

Trial Information

NCT ID

NCT00720902

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Columbia University

Last Updated

December 15, 2025

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