BARI-INSIGHT Version 1
Research type
Research Study
Full title
A double-blind, placebo-controlled, within-subject, crossover mechanistic study investigating the role of ghrelin in regulating appetite and energy intake in patients following bariatric surgery.
IRAS ID
240569
Contact name
Rachel L. Batterham
Contact email
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Z6364106/2018/05/128, Data Protection Registration
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Bariatric surgery helps patients with severe obesity to lose weight, cures and prevents diseases linked to obesity and reduces the risk of death. Unfortunately, 1 in 5 patients do not respond well to surgery in terms of weight loss and health gains. Thus, maximising weight loss and health benefits after surgery is critical. This study aims to gain insight into the role that the appetite-stimulating hormone, ghrelin, plays in driving appetite and energy intake in patients with poor weight loss (≤ 20% total body weight) following bariatric surgery. Active ghrelin levels will be reduced by inhibiting ghrelin-o-acyl-transferase (GOAT), the enzyme needed to generate active ghrelin (acyl-ghrelin (AG). The effect of AG reduction on appetite and energy intake will be evaluated. Patients with altered ghrelin response, identified during screening as part of BARI-OPTIMISE trial, and fulfilling BARI-INSIGHT inclusion/exclusion criteria will be invited to take part. Participants (30 in total) will attend a baseline assessment and then randomised to receive GLWL-01 (GOAT inhibitor) (300mg BD)/placebo, for 10 days. After a 6-10-week washout period, participants will attend a repeat baseline visit and crossed over to receive placebo/GLWL-01 300mg BD for the second 10-day study cycle. Study visits will take place on days 7 and 10 of each study cycle. At each visit, body weight, body composition, appetite, food cravings, adipokines, gut hormones, cytokines and inflammatory markers will be assessed. On day 7, participants will be assessed before and after eating a standardised (approximately 750 kcal) meal, whereas on day 10, ad libitum energy intake from a buffet will be assessed. Targeted physical examinations and assessment of adverse events will be performed. Safety monitoring calls will be performed on day 2 and 7 after the last dose of each study cycle. The end–of-study call will be undertaken after the second 6-10-week washout period.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/1342
Date of REC Opinion
9 Oct 2018
REC opinion
Further Information Favourable Opinion