IGF-I Induced Muscle Glucose Uptake and Interstitial IGF-I Concentrations

What Was Tested

In this not phased trial, researchers set out to test IGF-1 LR3.

Hormonal disturbances in the GH-IGF-I axis are considered important for the deterioration of glycemic control in T1DM particularly in adolescents.

In addition it may have direct implications on the development of insulin resistance and long-term complications.

It had two arms (groups): Saline (placebo comparator) and Increlex (active comparator).

The registry classes the interventions as drug.

More on the Plan

Therefore insulin given subcutaneously results in a relative insulin deficiency in the portal circulation of the liver, and a relative insulin excess in peripheral tissues.

In comparison, normal physiological delivery of insulin from the pancreas to the portal circulation, results in markedly higher hepatic insulin exposure.

While locally produced IGF-I is important for linear growth, circulating IGF-I is essential for insulin sensitivity (3).

Portal insulin deficiency results in uncoupling of GH induced IGF-I synthesis and subnormal circulating IGF-I levels in T1DM children with conventional therapy (4).

Who Took Part

8 actual participants took part.

It was open to people of any sex aged from 18 years up to 23 years.

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

Examples of who could join: Type 1 diabetes duration at least two years and assumed C-peptide negativity. Chronological age from 18 to 25 years. Levemir or Lantus as basal analogue or CSII. Written informed consent.

The full record lists 6 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

Because people in this IGF-1 LR3 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

In this single-blind IGF-1 LR3 study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2011-04 with completion listed for 2011-09.

It ran at 1 site in Sweden.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Difference in MD (microdialysate) IGF-1 over time (expressed as AUC or peak microdialysate IGF-I) between saline and IGF-I injection (time frame: 0-4 hours from injection).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of IGF-1 LR3 in 8 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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