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

NCT ID: NCT00684957

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-10-31

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.

Conditions

Growth Hormone Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Recombinant Human Growth Hormone first

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.

Group Type: ACTIVE_COMPARATOR

Recombinant Human Growth Hormone

Intervention Type: DRUG

300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)

Recombinant Human IGF-1

Intervention Type: DRUG

30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)

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.

Group Type: ACTIVE_COMPARATOR

Recombinant Human Growth Hormone

Intervention Type: DRUG

300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)

Recombinant Human IGF-1

Intervention Type: DRUG

30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)

Interventions

Recombinant Human Growth Hormone

300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)

Intervention Type: DRUG

Recombinant Human IGF-1

30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)

Intervention Type: DRUG

Other Intervention Names

rhGH; rhIGF-1

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tercica

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Pamela U. Freda

Professor of Medicine at the Columbia University Medical Center, Dept of Medicine Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela U. Freda, M.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University, College of Physicians and Surgeons

New York, New York, United States

Countries

United States

Other Identifiers

Tercica-001

Identifier Type: OTHER

Identifier Source: secondary_id

AAAC2883

Identifier Type: -

Identifier Source: org_study_id