Effect of Liraglutide (Victoza) on Inflammation in Human Adipose Tissue and Blood

What Was Tested

This registered phase 1 trial tested Liraglutide.

This will be done after 4 weeks of treatment during which weight will remain stable, and again after 12 weeks, during which liraglutide-related weight loss occurs.

It had two arms (groups): Liraglutide group (experimental) and Placebo group (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

These cells can exist in two states: M2, which can inhibit classical inflammatory response, and M1 which secrete proinflammatory cytokines.

The purpose of this study is to quantify macrophage phenotype (M1 vs M2) in subcutaneous adipose tissue in moderately-obese diet controlled diabetics at baseline, after four weeks of weight-maintenance using liraglutide, and after 12 weeks of liraglutide treatment as compared to placebo.

Aim 1: Quantify M1 and M2 (surface and intracellular markers) polarization via flow cytometry in subcutaneous abdominal adipose tissue and peripheral blood mononuclear cells at baseline and after 4 weeks administration of liraglutide versus placebo to weight-stable, obese, type 2 diabetic patients.

To eliminate confounding by weight loss, a placebo-treated group will undergo matched dietary weight loss for comparison to the liraglutide group to ascertain whether changes in macrophage polarization at 12 weeks are greater in the liraglutide group.

Who Took Part

Enrollment: 56 actual participants took part.

It was open to people of any sex aged from 40 years up to 69 years.

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

Examples of who could join: BMI between 25 and 42 kg/m2. HbA1C between 6.0 - 7.9 (those on Metformin must have a HbA1c level below 7.5 prior to wash-out period). Women must be post-menopausal or surgically sterile within age range.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: prior bariatric surgery; personal or family history of medullary thyroid cancer; MEN2 Syndrome.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

The Liraglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

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

It started in 2015-01 with completion listed for 2019-09-27.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Macrophage polarization: % M2 macrophages in adipose tissue and peripheral blood according to positivity for cell surface markers (measured by flow cytometry) (time frame: 30 months).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 56 people.

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

More context: the Liraglutide compound page, all human trials.