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

November 2, 2012 updated by: Columbia University

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

Intervention / Treatment

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 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 MRI findings (in the event of a known pituitary mass) will be recruited for the study.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Subject taking growth hormone
Drug: Recombinant Human Growth Hormone
300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)
Active Comparator: 2
Subject taking recombinant human IGF-1
Drug: Recombinant human IGF-1
30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular serum risk markers including lipids, IL-6, CRP and homocysteine
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in visceral adiposity, intrahepatic and intramyocellular lipids
Time Frame: 2 months
2 months
Changes in endothelial cell function
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Tercica

Investigators

  • Principal Investigator: Pamela U. Freda, M.D., Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimate)

May 28, 2008

Study Record Updates

Last Update Posted (Estimate)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 2, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAC2883
  • Tercica-001 (Other Identifier: Tercica)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Growth Hormone Deficiency

Clinical Trials on Recombinant Human Growth Hormone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe