Study Stopped
poor enrollment
Adult Growth Hormone Deficiency and Cardiovascular Risk
Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas
2 other identifiers
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 16, 2008
CompletedFirst Posted
Study publicly available on registry
July 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
November 16, 2022
CompletedNovember 16, 2022
October 1, 2022
3.1 years
June 16, 2008
February 2, 2017
October 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
C-reactive Protein (CRP) Levels
C-reactive protein (CRP) levels in GH sufficient and GH deficient participants
Day 1
Homocysteine Level
Homocytsteine levels in GH sufficient and GH deficient participants
Day 1
Total Cholesterol Level
Total cholesterol levels in GH sufficient and GH deficient participants
Day 1
Secondary Outcomes (8)
Percentage of Fat Measured by DXA DEXA
Day 1
Lean Body Mass by DXA DEXA
Day 1
Insulin Sensitivity as Assessed by Fasting Insulin Levels
Day 1
Glucose Levels as Assessed by an Oral Glucose Tolerance Test
Day 1
Endothelial Function as Assessed by Flow Mediated Dilatation and Endothelial Cell Biopsy
Day 1
- +3 more secondary outcomes
Study Arms (2)
A - Normal growth hormone secretion
ACTIVE COMPARATORPatients 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.
B - Growth hormone deficient
ACTIVE COMPARATORPatients 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.
Interventions
Subjects will have serum cardiovascular markers assessed
Subjects will receive GHRH and arginine intravenously and then have blood drawn at frequent intervals over a 90 minutes to assess growth hormone secretion.
Subjects will have an ultrasound of their neck to assess their carotid arteries to look for intima-medial thickness.
Subjects will have MRI and MR spectroscopy of the abdomen and lower extremities to assess for fat in internal organs and muscle.
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.
Eligibility Criteria
You may qualify if:
- Adults 19 years or older who have undergone transsphenoidal surgery for a clinically non-secreting pituitary adenoma
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University, College of Physicians and Surgeons
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pamela Freda, MD
- Organization
- Columbia University
Study Officials
- STUDY DIRECTOR
John C Ausiello, MD
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
June 16, 2008
First Posted
July 23, 2008
Study Start
February 1, 2007
Primary Completion
March 1, 2010
Study Completion
May 1, 2011
Last Updated
November 16, 2022
Results First Posted
November 16, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share