Effect of liraglutide on weight loss in patients with inadequate weight loss following bariatric surgery

Phase 4

Completed

• Conditions: Obesity; Failure of adequate weight loss following Laparoscopic Adjustable Gastric Band; Diet and Nutrition - Obesity

• Registration Number: ACTRN12617001613392
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-08
• Study Completion: 2023-11-11
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Patients will be considered for inclusion if they are 12-18 months post LAGB, have achieved a stable weight but have not achieved 12% total body weight loss; are 20-65 years of age. A Stable Weight” is defined as a weight that is consistent within a 4 kg range over a 3 month period.

Exclusion Criteria

Patients will be excluded from this study if they: have hypersensitivity to liraglutide or any of its excipients; have a past history of GLP-1 analogue associated pancreatitis; will not accept the randomisation process; have a correctable mechanical issue with the LAGB that could explain the lack of weight loss; have a history of previous obesity surgery other than LAGB; have medical issues which contraindicate the application of either arm of the study such as acute myocardial infarction within the past 6 months, dementia, bulimia, active psychosis, concurrent experimental drug use, current pregnancy, lactation, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy, or major organ failure; have used a GLP-1 agonist in the previous 12 months; are unable to understand the risks, realistic benefits and compliance requirements of the interventions.
There has been an increase in thyroid cancer reported in rodent models that have utilised liraglutide 3.0 mg and whilst this has not been validated in humans, patients with a personal or family history of medullary thyroid cancer will be excluded. Pancreatitis has been identified as a potential side effect although no studies to date have confirmed this. Because of this concern patient who are at risk of pancreatitis for other reasons (drugs, excessive alcohol intake, known symptomatic gallstones) will be excluded. Nausea is an expected side effect of liraglutide 3.0 mg and it is possible that the gastric band will need to be deflated acutely if the nausea is severe and causes vomiting. Therefore, patients who reside more than one hour from the Clinic will be excluded. Tachycardia is an occasional side effect of liragulatide 3.0 mg with the mechanism currently unknown. Patients with known tachycardia will therefore be excluded. Patients with congestive heart failure NY-HA class III-IV or inflammatory bowel disease will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the total body weight loss,achieved, measured in %, one year from the commencement of the trial, using clinician assessment and calibrated digital scales.[ One Year]