Conditions: Growth Hormone Deficiency
Keywords: rhGH rhIGF-1
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 5
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Recombinant Human Growth Hormone intervention 2: Recombinant Human IGF-1
Intervention descriptions: intervention 1: 300 mcg sc qd (which may be increased to 400 mcg sc qd after 4 weeks) intervention 2: 30 µg/kg for first 4 weeks (may be increased thereafter based on IGF-1 levels)

Protocol document: