GLIDE: Gastric band and Liraglutide Intervention in Diabetes Evolution
Research type
Research Study
Full title
The Impact of the Combination of the GLP-1 Analogue Liraglutide (Victoza®) and Laparoscopic Adjustable Gastric Banding (LAGB) on Diabetes Control
IRAS ID
166224
Contact name
Barbara McGowan
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Eudract number
2015-005402-11
Duration of Study in the UK
3 years, 8 months, 31 days
Research summary
What is the impact of the combination of liraglutide and gastric banding on diabetes control?
Obesity and T2DM continue to increase in prevalence causing an enormous impact on the health of individuals and the wider health economy. Weight loss surgery is increasingly seen as a potent and cost-effective intervention for the control of T2DM, but exactly which procedure to employ and in which circumstances remains uncertain. Expert opinion leans towards alternative procedures to the gastric band as having a greater impact on diabetes. However, they also have a higher complication rate. In practice, many patients instinctively prefer the idea of a reversible procedure (the band) over irreversible changes to their anatomy (as with sleeve gastrectomy or gastric bypass).
Studies suggest other procedures exert their effect on diabetes in large part by causing and increase in a hormone, GLP-1. GLP-1 based pharmaceuticals are frequently used for treating T2DM. The study will assess whether using pharmaceutical GLP-1 to mimic the rise seen after other weight-loss procedures will significantly improve the effect of gastric banding on diabetes control.
The study will be multi-centre, recruiting patients with T2DM and obesity from several NHS hospitals in England. Aspects of their physical and psychological health and their diabetes control will be assessed prior to surgery through physical examination, blood and urine tests and questionnaires. They will be randomly assigned to receive either active liraglutide or an inactive substitute (placebo), beginning 6 weeks after surgery. They will be reassessed at time intervals of 3 months. Liragltuide/placebo therapy will continue for 6 months, then subjects will be followed and reassessed for a further 6 months off treatment.
The study is funded by Novo Nordisk, who manufacture liraglutide. Novo Nordisk have no control over the conduct of the study.REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/1144
Date of REC Opinion
8 Jul 2016
REC opinion
Favourable Opinion