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

Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency

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.

Study Overview

• Status: Terminated
• Conditions: Growth Hormone Deficiency
• Intervention / Treatment: Drug: Recombinant Human Growth Hormone; Drug: Recombinant Human IGF-1

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University, College of Physicians and Surgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Recombinant Human Growth Hormone; 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks); Other Names: rhGH; Drug: Recombinant Human IGF-1; 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels); Other Names: rhIGF-1
Active Comparator: 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.	Drug: Recombinant Human Growth Hormone; 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks); Other Names: rhGH; Drug: Recombinant Human IGF-1; 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels); Other Names: rhIGF-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids	2 months
Changes in Endothelial Cell Function	2 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Tercica
• Investigators: Principal Investigator: Pamela U. Freda, M.D., Columbia University

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: May 23, 2008
• First Submitted That Met QC Criteria: May 27, 2008
• First Posted (Estimated): May 28, 2008

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: rhGH; rhIGF-1
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Pituitary Diseases; Dwarfism; Bone Diseases, Developmental; Hypopituitarism; Dwarfism, Pituitary; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: AAAC2883; Tercica-001 (Other Identifier: Tercica)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No