Effect of Liraglutide on Cardiovascular Endpoints in Diabetes Mellitus Type 2 Patients of South Asian Descent

What Was Tested

The trial (phase 4) is built around Liraglutide for fatty liver & elevated liver enzymes.

The effect of Liraglutide (Victoza®) on cardiovascular function is therefore investigated in the DM2 patient group of South Asian descent specifically.

Liraglutide is a new widely prescribed therapeutic agent for DM2 patients.

It had two arms (groups): Liraglutide (active comparator) and Liraglutide - Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Patients own physicists will be asked to point eligible patients to the opportunity of study participation.

If interested, patients will be informed by the principal investigator.

Furthermore laboratory tests and rest-ECG will be performed.

If the patient is eligible and willing to participate in the study, and has signed the informed consent, the patient will be included.

Who Took Part

Enrollment: 51 actual participants took part.

It was open to people of any sex aged from 19 years up to 74 years.

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

Examples of who could join: Age \> 18 years and \< 75 years. BMI \> 23 kg/m2.

The full record lists 7 inclusion and 20 exclusion criteria; among the exclusions: use of thiazolidinediones (tzd), glp-1 analogues, dpp-iv inhibitors, fibrates, prednisone, cytostatic or antiretroviral therapy within 6 months prior to the study; uncontrolled treated or untreated hypertension (systolic blood pressue ≥ 180 mmhg and/or diastolic blood pressue ≥ 110 mmhg); acute coronary or cerebrovascular event within 30 days prior to study.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

Blinding on both sides kept the fatty liver & elevated liver enzymes participants and researchers unaware of who received Liraglutide.

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

It started in 2015-08 with completion listed for 2018-03-09.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Stroke volume (time frame: 0 and 26 weeks). Ejection Fraction (time frame: 0 and 26 weeks). Cardiac output (time frame: 0 and 26 weeks).

It also tracked 12 secondary outcomes, for example Aorta vessel wall imaging, Carotid vessel wall imaging, Adipose tissue distribution, Total body fat, Epicardial fat volume and Magnetic Resonance Spectroscopy of the heart.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 51 people with fatty liver & elevated liver enzymes.

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

More context: the Liraglutide compound page, Fatty liver & elevated liver enzymes research.