BARI-OPTIMISE Version 1
Research type
Research Study
Full title
A double-blinded, randomised, placebo-controlled trial of liraglutide 3.0 mg in patients with poor weight-loss and a suboptimal glucagon-like peptide-1 response following bariatric surgery.
IRAS ID
225990
Contact name
Rachel Batterham
Contact email
Sponsor organisation
Joint Research Office
Eudract number
2017-002407-10
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Z6364106/2017/12/103, UCL Data Protection Registration Number; U1111-1185-8283, Universal Clinical Trial Number
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
Bariatric (weight loss) surgery helps people with severe obesity (dangerously high body fat levels) to lose weight, cures or prevents diseases linked to obesity and reduces the risk of dying. Unfortunately, 1 in 5 patients does not respond well to surgery in terms of weight loss and health gains. Access to surgery is limited, and the surgery itself carries a small risk of dying. Thus, making sure that patients lose weight and gain the most health benefit after surgery is critical.
This study aims at investigating whether ‘poor’ weight-loss response after surgery can be improved using a personalised pharmaceutical intervention tailored to the patient’s post-surgery biology. We will compare the changes that occur in body weight, relative amount of body fat and quality of life in people receiving daily injection of liraglutide 3.0mg compared to a control group receiving placebo.
Patients one-year or more following primary gastric bypass or primary sleeve gastrectomy with 'poor' weight-loss response fulfilling study criteria will be recruited from UCLH and Whittington Hospital. Patients will undergo a screening visit including a meal test for which they will have to consent. A second consent will be sought from those screening positive before being randomly assigned to receive either a daily injection of liraglutide 3.0mg or placebo for 24 weeks. 70 participants will be enrolled.
Assessments will be undertaken before and after the treatment. These include bodyweight, body composition (body fat,muscle,bone mass), physical fitness and activity, food and medication intake, blood test, meal test, health status and general well-being. For safety purposes, participants will attend for monitoring visits at approximately weeks 2, 4, 8, 17 and 24 of enrolment. All study data and adverse events will be documented in the trial CRF and medical records. End of trial visit will be carried out over the phone at week 28.REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/0030
Date of REC Opinion
6 Mar 2018
REC opinion
Further Information Favourable Opinion