Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients

What Was Tested

The trial (phase 3) is built around Liraglutide.

However there are no studies till date which have evaluated the combined effects of two modalities of weight loss on the above mentioned parameters.

This study plans to compare the effects of liraglutide in post- LSG obese patients in a placebo controlled design.

It had two arms (groups): Post LSG with Liraglutude (experimental) and Post LSG without Liraglutide (placebo comparator).

Normal Saline in equivalent per day subcutaneously once a day.

The registry classes the interventions as drug.

More on the Plan

The degree of effect on obesity related comorbidities depends on the bariatric surgery approach, typically classified as restrictive and/or malabsorptive effect.

LSG is technically a simpler procedure compared to RYGB with lesser operative and long term nutritional complications.

The mechanism for weight loss in laparoscopic sleeve gastrectomy is gastric restriction and possible changes in gut hormones resulting from higher level of GLP-1, and lower levels of ghrelin, as a consequence of resection of gastric fundus.

This study plans to compare the effects of liraglutide in post- LSG obese participants in a placebo controlled design.

Who Took Part

The registry lists 16 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Subjects diagnosed with obesity who have elected to undergo bariatric surgery. Body mass index greater than 27.5kg/mt2. Ability and willingness to co-operate with follow up.

The full record lists 3 inclusion and 17 exclusion criteria; among the exclusions: recurrent major hypoglycemic episodes; use of drugs like systemic corticosteroids, thiazolidinediones, dppiv inhibitors; pregnancy or lactation.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

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

It started in 2016-08-01 with completion listed for 2018-12-31.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incretin change (time frame: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy). Changes in indices of insulin resistance (time frame: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy). Change in pancreatic steatosis (time frame: baseline and 6months after laparoscopic sleeve gastrectomy).

It also tracked 1 secondary outcome, for example body weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 16 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 Liraglutide compound page, all human trials.