The Effect of Liraglutide on Dietary Lipid Induced Insulin Resistance in Humans

What Was Tested

The trial (phase 4) is built around Liraglutide for insulin resistance, prediabetes & type 2 diabetes.

It had two arms (groups): Liraglutide (experimental) and Sugar pill (placebo comparator).

Matching placebo and titration.

The registry classes the interventions as drug.

More on the Plan

The specific aim of this study is to determine the ability of subacute liraglutide administration to protect against dietary lipid induced peripheral insulin resistance in non-diabetic subjects who have normal glucose tolerance.

This is presumably mediated in part through delivery of lipids and lipid products generated during postprandial lipolysis into non-adipose tissue.

This unique model therefore provides an excellent platform to test agents for their ability to inhibit dietary induced insulin resistance.

Who Took Part

97 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Age 40-75 years old. Body mass index (BMI) from 22 to 35 kg/m2.

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: any diabetes medications in the past month, thiazolidinedione medications in the prior 3 months or prior regular use of insulin; lactose intolerance or avoidance of dairy products; known 'nonalcoholic fatty liver disease'.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

The insulin resistance, prediabetes & type 2 diabetes participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

In the crossover set-up each of the insulin resistance, prediabetes & type 2 diabetes participants took both Liraglutide and the comparison in turn, acting as their own control.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-03 with completion listed for 2021-04-28.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Whole Body Insulin Sensitivity (insulin suppression test) (time frame: 3 weeks).

It also tracked 9 secondary outcomes, for example Postprandial changes in glucose metabolism (total and incremental area under the curve differences in glucose, insulin and glucagon), subcutaneous adipose tissue lipid intermediates (e.g., ceramide, diacylglycerol, acylcarnitine concentrations), skeletal muscle tissue lipid intermediates (e.g., ceramide, diacylglycerol, acylcarnitine concentrations), Skeletal muscle inflammation measures (e.g., IL-6,8, TNF-alpha, nuclear factor-kappa b gene and protein expression), Adipose tissue arteriole function (vasodilation measurement) and Changes in skeletal muscle insulin signaling pathway.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 97 people with insulin resistance, prediabetes & type 2 diabetes.

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

More context: the Liraglutide compound page, Insulin resistance, prediabetes & type 2 diabetes research.