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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00684957
Recruitment Status : Terminated (Poor enrollment)
First Posted : May 28, 2008
Last Update Posted : November 6, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: Recombinant Human Growth Hormone Drug: Recombinant human IGF-1 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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)

Primary Outcome Measures :
  1. Cardiovascular serum risk markers including lipids, IL-6, CRP and homocysteine [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Changes in visceral adiposity, intrahepatic and intramyocellular lipids [ Time Frame: 2 months ]
  2. Changes in endothelial cell function [ Time Frame: 2 months ]

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00684957

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

Responsible Party: Columbia University Identifier: NCT00684957     History of Changes
Other Study ID Numbers: AAAC2883
Tercica-001 ( Other Identifier: Tercica )
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: November 6, 2012
Last Verified: November 2012

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