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

NCT06201819 | Completed Phase 4

• 1 other identifier: CEI-008-20161212
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Bariatric Surgery Candidate; Obesity, Morbid

Keywords

Preoperative weight loss

Outcome Measures

Primary Outcomes (1)

• Preoperative weight changes

  Total body weight change during the drug administration

  3 months

Study Arms (1)

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

Drug: Liraglutide injection

Interventions

Liraglutide injection DRUG

Liraglutide (GLP-1 analog) injection during 3 months

Patients with morbid obesity in bariatric surgery preparation protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unidad de Cirugia Bariatrica Hospital Civil Dr. Juan I. Menchaca: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Weight Loss; Obesity, Morbid

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bariatric Surgery Resident

Model Details: quasi-experimental prospective before-and-after study.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 11, 2024
• Study Start: December 18, 2022
• Primary Completion: March 18, 2023
• Study Completion: May 1, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 months
• Access Criteria: Available on request to the main author

Locations

ME (1)