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NCT06201819 Clinical Trial

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

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06201819
Other study ID # CEI-008-20161212
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 18, 2022
Est. completion date May 1, 2023

Study information
Verified date January 2024
Source Unidad de Cirugia Bariatrica Hospital Civil Dr. Juan I. Menchaca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date May 1, 2023
Est. primary completion date March 18, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Liraglutide injection
Liraglutide (GLP-1 analog) injection during 3 months

Locations
Country Name City State
Mexico Departamento de Cirugia Bariatrica y Metabolica del Hsopital Civil Dr. Juan I. Menchaca Guadalajara Jalisco

Sponsors (1)
Lead Sponsor Collaborator
Unidad de Cirugia Bariatrica Hospital Civil Dr. Juan I. Menchaca

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Preoperative weight changes Total body weight change during the drug administration 3 months
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