Adult Growth Hormone Deficiency and Cardiovascular Risk

Growth Hormone Deficiency Clinical Trial

Official title:

Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00720902
• Other study ID #: AAAB9681 (Serono-001)
• Secondary ID: Serono-001
• Status: Terminated
• Phase: Phase 4
• Start date: February 2007
• Est. completion date: May 2011

Study information

• Verified date: October 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency

Intervention

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.
• MRI
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
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.

Locations

Country	Name	City	State
United States	Columbia University, College of Physicians and Surgeons	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-reactive Protein (CRP) Levels	C-reactive protein (CRP) levels in GH sufficient and GH deficient participants	Day 1
Primary	Homocysteine Level	Homocytsteine levels in GH sufficient and GH deficient participants	Day 1
Primary	Total Cholesterol Level	Total cholesterol levels in GH sufficient and GH deficient participants	Day 1
Secondary	Percentage of Fat Measured by DXA DEXA	Percentage of total body fat and trunk fat as measured by DXA	Day 1
Secondary	Lean Body Mass by DXA DEXA	Lean body mass as measured by DXA	Day 1
Secondary	Insulin Sensitivity as Assessed by Fasting Insulin Levels	Insulin sensitivity as assessed by fasting insulin levels	Day 1
Secondary	Glucose Levels as Assessed by an Oral Glucose Tolerance Test	Glucose levels as assessed by an oral glucose tolerance test	Day 1
Secondary	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.	Day 1
Secondary	Carotid Intimal-medial Thickness Studies as Assessed by Ultrasound	Carotid intimal-medial thickness studies will be measured by ultrasound	Year 1
Secondary	Intramyocellular Lipid Content Using MRI and MR Spectroscopy	Intramyocellular lipid content using MRI and MR spectroscopy of the soleus muscle was performed.	Day 1
Secondary	Intrahepatic Lipid Content Using MRI and MR Spectroscopy	Intrahepatic lipid (IHL) content using MRI and MR spectroscopy of the liver was performed.	Day 1