Skip to main content
Clinical Trials/NCT06201819
NCT06201819CompletedPhase 4

Liraglutide Effectiveness in Preoperative Weight-loss for Patients With Severe Obesity Undergoing Bariatric-metabolic Surgery.

Unidad de Cirugia Bariatrica Hospital Civil Dr. Juan I. Menchaca1 site in 1 country37 target enrollmentStarted: December 18, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
37
Locations
1
Primary Endpoint
Preoperative weight changes

Study Overview

Brief Summary

Severe obesity is associated with considerable reduction of wellbeing and life expectancy. 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. The effectiveness of GLP-1 analogue Liraglutide in preoperative weight-loss was evaluated in the study.

Detailed Description

Objective

Determine liraglutide effectiveness for preoperative weight-loss in patients with severe obesity undergoing bariatric-metabolic surgery.

Methods:

It is a single center, quasi-experimental prospective before-and-after study. All patients were assigned the same pharmacological treatment with liraglutide, initiating dosing with 0.6 mg per day escalating 0.6 mg every week up to 3.0 mg. The treatment dose was delivered once daily via subcutaneous injection for 3 months (12 weeks). Weight-loss and percentage weight-loss was evaluated monthly using bioelectric impedance (BIA) final result at week 12.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with BMI greater than 48 kg/m2 in pre-surgical protocol for bariatric surgery of the Bariatric and Metabolic Surgery Unit of the Civil Hospital of Guadalajara "Dr. Juan I. Menchaca

Exclusion Criteria

  • 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.
  • Patients with allergy to liraglutide, multiple endocrine neoplasia type 2 and medullary thyroid cancer, gallstones.
  • Patients who decide to abandon the study.
  • Patients who do not follow the instructions or do not adhere to the treatment.

Arms & Interventions

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

Intervention: Liraglutide injection (Drug)

Outcomes

Primary Outcomes

Preoperative weight changes

Time Frame: 3 months

Total body weight change during the drug administration

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Unidad de Cirugia Bariatrica Hospital Civil Dr. Juan I. Menchaca
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jose Daniel Reyes Blandón

Bariatric Surgery Resident

Unidad de Cirugia Bariatrica Hospital Civil Dr. Juan I. Menchaca

Study Sites (1)

Loading locations...

Similar Trials

Recruiting
Phase 4
Efficacy and Safety of Liraglutide in the Treatment of Obesity Combined With Metabolism Associated Fatty Liver DiseaseNon-alcoholic Fatty Liver DiseaseObesity
NCT06501326Affiliated Hospital of Nantong University102
Active, not recruiting
Phase 1
Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetes A 56 week randomised, double-blind, placebo-controlled, three armed parallel group, multi-centre, multinational trial with a 12 week observational follow-up period - SCALE™ - DiabetesObesity and overweightMedDRA version: 14.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.0 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2008-002199-88-GBovo Nordisk A/S
Active, not recruiting
Not Applicable
Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetesA 56 week randomised, double-blind, placebocontrolled, three armed parallel group, multi-centre, multinational trial with a 12 week observational follow-up period - SCALE™ - DiabetesObesity and overweightMedDRA version: 14.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.0Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2008-002199-88-SEovo Nordisk A/S800
Active, not recruiting
Phase 1
Effect of liraglutide on body weight in overweight orobese subjects with type 2 diabetesA 1 year randomised, double-blind, placebo-controlled,three armed parallel group, multi-centre, multinationaltrial with a 12 week observational follow-up periodObesity and overweightMedDRA version: 9.1Level: LLTClassification code 10029883Term: ObesityMedDRA version: 9.1Level: LLTClassification code 10033307Term: Overweight
EUCTR2008-002199-88-FRovo Nordisk A/S
Active, not recruiting
Not Applicable
Effect of liraglutide on body weight in overweight or obese subjects with type 2 diabetesA 56 week randomised, double-blind, placebocontrolled, three armed parallel group, multi-centre, multinational trial with a 12 week observational follow-up period - SCALE™ - DiabetesObesity and overweightMedDRA version: 14.1Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders
EUCTR2008-002199-88-DEovo Nordisk A/S800