NCT00684957

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Male
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 growth hormone (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 magnetic resonance imaging (MRI) findings (in the event of a known pituitary mass) will be recruited for the study.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2008-05-28
• Last updated: 2024-07-17
• Results posted: 2024-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study