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Adult Growth Hormone Deficiency and Cardiovascular Risk

NCT00720902 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-11-16

Study results available
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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.

Conditions

  • Growth Hormone Deficiency

Interventions

PROCEDURE

Blood draws

Subjects will have serum cardiovascular markers assessed

DRUG

growth hormone releasing hormone (GHRH) & arginine

Subjects will receive GHRH and arginine intravenously and then have blood drawn at frequent intervals over a 90 minutes to assess growth hormone secretion.

PROCEDURE

Carotid ultrasound

Subjects will have an ultrasound of their neck to assess their carotid arteries to look for intima-medial thickness.

PROCEDURE

MRI

Subjects will have MRI and MR spectroscopy of the abdomen and lower extremities to assess for fat in internal organs and muscle.

PROCEDURE

Endothelial cell biopsy

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.

Sponsors & Collaborators

Principal Investigators

  • John C Ausiello, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-03-31
Completion
2011-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00720902 on ClinicalTrials.gov