Adult Growth Hormone Deficiency and Cardiovascular Risk

NCT ID: NCT00720902

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2011-05-31

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.

Conditions

Growth Hormone Deficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

A - Normal growth hormone secretion

Patients who have undergone transsphenoidal surgery for a pituitary adenoma and have normal growth hormone secretion: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) \& arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.

Group Type: ACTIVE_COMPARATOR

Blood draws

Intervention Type: PROCEDURE

Subjects will have serum cardiovascular markers assessed

growth hormone releasing hormone (GHRH) & arginine

Intervention Type: DRUG

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

Carotid ultrasound

Intervention Type: PROCEDURE

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

MRI

Intervention Type: PROCEDURE

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

Endothelial cell biopsy

Intervention Type: PROCEDURE

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.

B - Growth hormone deficient

Patients who have undergone transsphenoidal surgery for pituitary adenoma who are growth hormone deficient: Subjects will undergo a clinical exam with vital signs and blood draws, anthropometric measurements and skin fold thickness assessments. Subjects will also undergo GH stimulation testing with growth hormone releasing hormone (GHRH) \& arginine, MRI and MR spectroscopy, carotid ultrasound, and have an endothelial cell biopsy.

Group Type: ACTIVE_COMPARATOR

Blood draws

Intervention Type: PROCEDURE

Subjects will have serum cardiovascular markers assessed

growth hormone releasing hormone (GHRH) & arginine

Intervention Type: DRUG

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

Carotid ultrasound

Intervention Type: PROCEDURE

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

MRI

Intervention Type: PROCEDURE

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

Endothelial cell biopsy

Intervention Type: PROCEDURE

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.

Interventions

Blood draws

Subjects will have serum cardiovascular markers assessed

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Carotid ultrasound

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

Intervention Type: PROCEDURE

MRI

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adults 19 years or older who have undergone transsphenoidal surgery for a clinically non-secreting pituitary adenoma

Exclusion Criteria

• Currently taking growth hormone, radiation therapy in the past 5 years, changes in dose of other pituitary hormone replacement therapy in past 3 months, taking hydrocortisone (or its equivalent) at a dose of > 30 mg/day, pregnant or nursing women

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Pamela U. Freda

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John C Ausiello, MD

Role: STUDY_DIRECTOR

Columbia University

Locations

Columbia University, College of Physicians and Surgeons

New York, New York, United States

Countries

United States

Other Identifiers

Serono-001

Identifier Type: OTHER

Identifier Source: secondary_id

AAAB9681 (Serono-001)

Identifier Type: -

Identifier Source: org_study_id