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

NCT ID: NCT06201819

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-18

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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Weight Loss Bariatric Surgery Candidate Obesity, Morbid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

quasi-experimental prospective before-and-after study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Liraglutide injection

Intervention Type DRUG

Liraglutide (GLP-1 analog) injection during 3 months

Interventions

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Liraglutide injection

Liraglutide (GLP-1 analog) injection during 3 months

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Jose Daniel Reyes Blandón

Bariatric Surgery Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Departamento de Cirugia Bariatrica y Metabolica del Hsopital Civil Dr. Juan I. Menchaca

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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CEI-008-20161212

Identifier Type: -

Identifier Source: org_study_id

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