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Adult Growth Hormone Deficiency and Cardiovascular Risk

Primary Purpose

Growth Hormone Deficiency

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Blood draws
growth hormone releasing hormone (GHRH) & arginine
Carotid ultrasound
MRI
Endothelial cell biopsy
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Growth Hormone Deficiency focused on measuring Growth hormone

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University, College of Physicians and Surgeons

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A - Normal growth hormone secretion

B - Growth hormone deficient

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

C-reactive Protein (CRP) Levels
C-reactive protein (CRP) levels in GH sufficient and GH deficient participants
Homocysteine Level
Homocytsteine levels in GH sufficient and GH deficient participants
Total Cholesterol Level
Total cholesterol levels in GH sufficient and GH deficient participants

Secondary Outcome Measures

Percentage of Fat Measured by DXA DEXA
Percentage of total body fat and trunk fat as measured by DXA
Lean Body Mass by DXA DEXA
Lean body mass as measured by DXA
Insulin Sensitivity as Assessed by Fasting Insulin Levels
Insulin sensitivity as assessed by fasting insulin levels
Glucose Levels as Assessed by an Oral Glucose Tolerance Test
Glucose levels as assessed by an oral glucose tolerance test
Endothelial Function as Assessed by Flow Mediated Dilatation and Endothelial Cell Biopsy
Endothelial function as assessed by flow mediated dilatation and endothelial cell biopsy for measurement of inflammatory markers.
Carotid Intimal-medial Thickness Studies as Assessed by Ultrasound
Carotid intimal-medial thickness studies will be measured by ultrasound
Intramyocellular Lipid Content Using MRI and MR Spectroscopy
Intramyocellular lipid content using MRI and MR spectroscopy of the soleus muscle was performed.
Intrahepatic Lipid Content Using MRI and MR Spectroscopy
Intrahepatic lipid (IHL) content using MRI and MR spectroscopy of the liver was performed.

Full Information

First Posted
June 16, 2008
Last Updated
October 24, 2022
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT00720902
Brief Title
Adult Growth Hormone Deficiency and Cardiovascular Risk
Official Title
Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
poor enrollment
Study Start Date
February 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency
Keywords
Growth hormone

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - Normal growth hormone secretion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B - Growth hormone deficient
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Blood draws
Intervention Description
Subjects will have serum cardiovascular markers assessed
Intervention Type
Drug
Intervention Name(s)
growth hormone releasing hormone (GHRH) & arginine
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Carotid ultrasound
Intervention Description
Subjects will have an ultrasound of their neck to assess their carotid arteries to look for intima-medial thickness.
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
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
Intervention Name(s)
Endothelial cell biopsy
Intervention 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 Outcome Measure Information:
Title
C-reactive Protein (CRP) Levels
Description
C-reactive protein (CRP) levels in GH sufficient and GH deficient participants
Time Frame
Day 1
Title
Homocysteine Level
Description
Homocytsteine levels in GH sufficient and GH deficient participants
Time Frame
Day 1
Title
Total Cholesterol Level
Description
Total cholesterol levels in GH sufficient and GH deficient participants
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Percentage of Fat Measured by DXA DEXA
Description
Percentage of total body fat and trunk fat as measured by DXA
Time Frame
Day 1
Title
Lean Body Mass by DXA DEXA
Description
Lean body mass as measured by DXA
Time Frame
Day 1
Title
Insulin Sensitivity as Assessed by Fasting Insulin Levels
Description
Insulin sensitivity as assessed by fasting insulin levels
Time Frame
Day 1
Title
Glucose Levels as Assessed by an Oral Glucose Tolerance Test
Description
Glucose levels as assessed by an oral glucose tolerance test
Time Frame
Day 1
Title
Endothelial Function as Assessed by Flow Mediated Dilatation and Endothelial Cell Biopsy
Description
Endothelial function as assessed by flow mediated dilatation and endothelial cell biopsy for measurement of inflammatory markers.
Time Frame
Day 1
Title
Carotid Intimal-medial Thickness Studies as Assessed by Ultrasound
Description
Carotid intimal-medial thickness studies will be measured by ultrasound
Time Frame
Year 1
Title
Intramyocellular Lipid Content Using MRI and MR Spectroscopy
Description
Intramyocellular lipid content using MRI and MR spectroscopy of the soleus muscle was performed.
Time Frame
Day 1
Title
Intrahepatic Lipid Content Using MRI and MR Spectroscopy
Description
Intrahepatic lipid (IHL) content using MRI and MR spectroscopy of the liver was performed.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C Ausiello, MD
Organizational Affiliation
Columbia University
Official's Role
Study Director
Facility Information:
Facility Name
Columbia University, College of Physicians and Surgeons
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Adult Growth Hormone Deficiency and Cardiovascular Risk

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