Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors

Phase 1

Terminated

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: Recombinant Human Growth Hormone; Drug: Recombinant Human IGF-1

• Registration Number: NCT00684957
• Lead Sponsor: Columbia University

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-1 act differently in some metabolic pathways. We will study the differences between GH and IGF-1 when provided as therapy for growth hormone deficiency in adults. Specifically we will be assessing if either medication impacts cardiovascular risk factors and if so do they impact risk factors differently. Ten adult males ages 18-65 who are growth hormone deficient on stable medications and with stable magnetic resonance imaging (MRI) findings (in the event of a known pituitary mass) will be recruited for the study.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2016-08-04
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-21
• Last Update Submitted: 2024-06-21
• Results First Posted: 2024-07-17
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 5

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Recombinant Human Growth Hormone first	Recombinant Human IGF-1	Subjects 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	Recombinant Human IGF-1	Subjects will take rhIGF1 for eight weeks followed by a two month wash out period and then will cross over to rhGH for eight weeks.
Recombinant Human Growth Hormone first	Recombinant Human Growth Hormone	Subjects 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	Recombinant Human Growth Hormone	Subjects will take rhIGF1 for eight weeks followed by a two month wash out period and then will cross over to rhGH for eight weeks.

Primary Outcome Measures

Name	Time	Method
Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine	2 months

Secondary Outcome Measures

Name	Time	Method
Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids	2 months
Changes in Endothelial Cell Function	2 months

Trial Locations

Locations (1)

Columbia University, College of Physicians and Surgeons; 🇺🇸 New York, New York, United States