Status:
TERMINATED
Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Tercica
Conditions:
Growth Hormone Deficiency
Eligibility:
MALE
25-65 years
Phase:
PHASE1
PHASE2
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.
Detailed Description
Insulin-like growth factor-1 (IGF-1) in some circumstances acts as the mediator of the metabolic effects of growth hormone. However, there is some evidence to suggest that growth hormone (GH) and IGF-...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00684957
Start Date
January 1 2008
End Date
October 1 2012
Last Update
July 17 2024
Active Locations (1)
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1
Columbia University, College of Physicians and Surgeons
New York, New York, United States, 10032