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

Sponsors and Collaborators:	Columbia University Tercica
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00684957

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

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate Mecasermin Somatotropin Somatropin

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	10
Study Start Date:	January 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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)
2: Active Comparator 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

Contacts

Contact: John C Ausiello, MD

212-305-6472

ja2395@columbia.edu

Locations

United States, New York
Columbia University, College of Physicians and Surgeons	Recruiting
New York, New York, United States, 10032
Contact: John C Ausiello, MD 212-305-6472 ja2395@columbia.edu
Principal Investigator: Pamela U Freda, MD

Sponsors and Collaborators

Columbia University

Tercica

Investigators

Principal Investigator:

Pamela U. Freda, M.D.

Columbia University Medical Center

More Information

Responsible Party:	Columbia University, College of Physician and Surgeons ( Pamela Freda )
Study ID Numbers:	Tercica-001, IRB-AAAC2883
Study First Received:	May 23, 2008
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00684957
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Dwarfism
Bone Diseases, Endocrine
Hypopituitary dwarfism
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases
Central Nervous System Diseases
Dwarfism, Pituitary

Brain Diseases
Bone Diseases
Growth hormone deficiency
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental
Endocrinopathy

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009