Study Stopped
Poor enrollment
Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors
2 other identifiers
interventional
5
1 country
1
Brief Summary
The purpose of this study is to see if giving growth hormone or insulin-like growth factor-1 (IGF-1) to subjects with growth hormone deficiency effects cardiovascular risk factors differently.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2008
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 23, 2008
CompletedFirst Posted
Study publicly available on registry
May 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
July 17, 2024
CompletedJuly 17, 2024
June 1, 2024
4.8 years
May 23, 2008
August 4, 2016
June 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine
2 months
Secondary Outcomes (2)
Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids
2 months
Changes in Endothelial Cell Function
2 months
Study Arms (2)
Recombinant Human Growth Hormone first
ACTIVE COMPARATORSubjects will take rhGH for eight weeks followed by a two month wash out period and then will cross over to rhIGF1 for eight weeks.
Recombinant Human IGF-1
ACTIVE COMPARATORSubjects will take rhIGF1 for eight weeks followed by a two month wash out period and then will cross over to rhGH for eight weeks.
Interventions
300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)
30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)
Eligibility Criteria
You may qualify if:
- Adult male age 25-65 with documented growth hormone deficiency on stable doses x 3 months (at least) of any hormone replacement therapies and with stable MRIs x 2 years in the setting of a known pituitary mass.
You may not qualify if:
- Female gender
- current GH use or GH use within three months of the study
- diabetes
- hypoglycemia
- liver or kidney disease
- use of drugs that could increase GH secretion (i.e. L-dopa)
- alcohol or substance abuse
- use of investigational drugs within four weeks of our study and use of supraphysiologic doses of steroids within the previous six months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Tercicacollaborator
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
- PRINCIPAL INVESTIGATOR
Pamela U. Freda, M.D.
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine at the Columbia University Medical Center, Dept of Medicine Endocrinology
Study Record Dates
First Submitted
May 23, 2008
First Posted
May 28, 2008
Study Start
January 1, 2008
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
July 17, 2024
Results First Posted
July 17, 2024
Record last verified: 2024-06