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Liraglutide Effectiveness in Preoperative Weight-loss for Bariatric-metabolic Surgery

Plain-language guide to NCT06201819: phase 4 interventional trial of Liraglutide, fat loss, obesity & body recomposition, 37 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06201819
Phase
phase 4
Status
completed
Start
2022-12-18
Completion (planned or actual)
2023-03-18
Participants
37 (actual)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Weight Loss; Bariatric Surgery Candidate; Obesity, Morbid
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide for fat loss, obesity & body recomposition.

People living with severe obesity tend to die 8 to 10 years earlier.

Preoperative management of patients living with severe obesity can be challenging and proper weight-loss may help obtain better outcomes and less morbidity.

It had 1 arm (groups): Patients with morbid obesity in bariatric surgery preparation protocol (experimental).

All patients with body mass index \>48 kg/m2 in preoperative protocol for bariatric surgery using liraglutide for preoperative weight loss.

The registry classes the interventions as drug.

More on the Plan

Methods: It is a single center, quasi-experimental prospective before-and-after study.

Weight-loss and percentage weight-loss was evaluated monthly using bioelectric impedance (BIA) final result at week 12.

Who Took Part

37 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: patients under 18 years of age or over 65 years of age; pregnant patients; patients who do not agree to give their consent and take part in the study.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-12-18 with completion listed for 2023-03-18.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Preoperative weight changes (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Liraglutide in 37 people with fat loss, obesity & body recomposition.

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, Fat loss, obesity & body recomposition research.

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.