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

May 23, 2008
November 2, 2012
January 2008
October 2012   (final data collection date for primary outcome measure)
Cardiovascular serum risk markers including lipids, IL-6, CRP and homocysteine [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00684957 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Growth Hormone Deficiency
  • Drug: Recombinant Human Growth Hormone
    300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)
  • Drug: Recombinant human IGF-1
    30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)
  • Active Comparator: 1
    Subject taking growth hormone
    Intervention: Drug: Recombinant Human Growth Hormone
  • Active Comparator: 2
    Subject taking recombinant human IGF-1
    Intervention: Drug: Recombinant human IGF-1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Male
25 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00684957
AAAC2883, Tercica-001
No
Columbia University
Columbia University
Tercica
Principal Investigator: Pamela U. Freda, M.D. Columbia University
Columbia University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP