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

Growth Hormone Deficiency Clinical Trial

Official title:

Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00684957
• Other study ID #: AAAC2883
• Secondary ID: Tercica-001
• Status: Terminated
• Phase: N/A
• First received: May 23, 2008
• Last updated: November 2, 2012
• Start date: January 2008
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

Drug:
• Recombinant Human Growth Hormone
300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks)
• Recombinant human IGF-1
30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)

Locations

Country	Name	City	State
United States	Columbia University, College of Physicians and Surgeons	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Tercica

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular serum risk markers including lipids, IL-6, CRP and homocysteine		2 months
Secondary	Changes in visceral adiposity, intrahepatic and intramyocellular lipids		2 months
Secondary	Changes in endothelial cell function		2 months