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

What Was Tested

This registered phase 1, phase 2 trial tested IGF-1 LR3.

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.

It had two arms (groups): Recombinant Human Growth Hormone first (active comparator) and Recombinant Human IGF-1 (active comparator).

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.

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.

The registry classes the interventions as drug.

More on the Plan

Insulin-like growth factor-1 (IGF-1) in some circumstances acts as the mediator of the metabolic effects of growth hormone.

The researchers will study the differences between GH and IGF-1 when provided as therapy for growth hormone deficiency in adults.

Specifically the researchers 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.

Who Took Part

Enrollment: 5 actual participants took part.

It was open to men only aged from 25 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: female gender; current gh use or gh use within three months of the study; liver or kidney disease.

How the Study Was Run

The set-up was randomized, crossover and open-label.

The participants were allocated by chance, so the IGF-1 LR3 group and the comparison group should start out alike.

In the crossover set-up each of the participants took both IGF-1 LR3 and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label IGF-1 LR3 study: the participants and staff both knew the treatment.

It started in 2008-01 with completion listed for 2012-10.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine (time frame: 2 months).

It also tracked 2 secondary outcomes, for example Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids and Changes in Endothelial Cell Function.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of IGF-1 LR3 in 5 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the IGF-1 LR3 compound page, all human trials.