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

Columbia University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Growth Hormone Deficiency

Treatments: Drug: Recombinant Human Growth Hormone; Drug: Recombinant Human IGF-1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00684957

AAAC2883

Tercica-001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Male

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Recombinant Human Growth Hormone first

Active Comparator group

Description:

Subjects will take rhGH for eight weeks followed by a two month wash out period and then will cross over to rhIGF1 for eight weeks.

Treatment:

Drug: Recombinant Human IGF-1

Drug: Recombinant Human Growth Hormone

Recombinant Human IGF-1

Active Comparator group

Description:

Subjects will take rhIGF1 for eight weeks followed by a two month wash out period and then will cross over to rhGH for eight weeks.

Treatment:

Drug: Recombinant Human IGF-1

Drug: Recombinant Human Growth Hormone