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

January 15, 2024 updated by: Jose Daniel Reyes Blandón, Unidad de Cirugia Bariatrica Hospital Civil Dr. Juan I. Menchaca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Departamento de Cirugia Bariatrica y Metabolica del Hsopital Civil Dr. Juan I. Menchaca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Removal:

  • Patients who decide to abandon the study.
  • Patients who do not follow the instructions or do not adhere to the treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with morbid obesity in bariatric surgery preparation protocol
All patients with body mass index >48 kg/m2 in preoperative protocol for bariatric surgery using liraglutide for preoperative weight loss
Drug: Liraglutide injection
Liraglutide (GLP-1 analog) injection during 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative weight changes
Time Frame: 3 months
Total body weight change during the drug administration
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2022

Primary Completion (Actual)

March 18, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

December 31, 2023

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-008-20161212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes

IPD Sharing Time Frame

3 months

IPD Sharing Access Criteria

Available on request to the main author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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