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

Phase 4

Completed

• Conditions: Weight Loss; Bariatric Surgery Candidate; Obesity, Morbid
• Interventions: Drug: Liraglutide injection

• Registration Number: NCT06201819
• Lead Sponsor: Unidad de Cirugia Bariatrica Hospital Civil Dr. Juan I. Menchaca

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 Timeline

• Study Start: 2022-12-18
• Primary Completion: 2023-03-18
• Study Completion: 2023-05-01
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-31
• Status Verified: 2024-01
• Study First Posted: 2024-01-11
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with morbid obesity in bariatric surgery preparation protocol	Liraglutide injection	All patients with body mass index \>48 kg/m2 in preoperative protocol for bariatric surgery using liraglutide for preoperative weight loss

Primary Outcome Measures

Name	Time	Method
Preoperative weight changes	3 months	Total body weight change during the drug administration

Trial Locations

Locations (1)

Departamento de Cirugia Bariatrica y Metabolica del Hsopital Civil Dr. Juan I. Menchaca; 🇲🇽 Guadalajara, Jalisco, Mexico