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

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborator:
Tercica
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00684957
First received: May 23, 2008
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Growth Hormone Deficiency
 Drug: Recombinant Human Growth Hormone
Drug: Recombinant human IGF-1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Cardiovascular serum risk markers including lipids, IL-6, CRP and homocysteine [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in visceral adiposity, intrahepatic and intramyocellular lipids [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Changes in endothelial cell function [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: January 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684957

Locations
United States, New York
Columbia University, College of Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Tercica
Investigators
Principal Investigator: Pamela U. Freda, M.D. Columbia University
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00684957     History of Changes
Other Study ID Numbers: AAAC2883, Tercica-001
Study First Received: May 23, 2008
Last Updated: November 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013