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

  59979

• Contact name

  Shahrad Taheri

• Sponsor organisation

  University of Birmingham

• Eudract number

  2011-001538-41

• Research summary

  What is the impact of combining liraglutide diabetes treatment and gastric banding on diabetes?The obesity pandemic is associated with a significant increase in numbers of patients with type 2 diabetes mellitus (T2DM). Diabetes has an enormous impact on individual patients and the NHS. Although weight loss would greatly benefit this population, diabetes treatments often exacerbate obesity making weight loss more difficult. Bariatric (obesity) surgery is an effective and superior method for treating extreme obesity and diabetes compared to lifestyle interventions and pharmacotherapy. Laparoscopic adjustable gastric band (LAGB) is a bariatric surgical procedure increasingly used worldwide. Although other bariatric surgery procedures produce more predictable weight reduction and diabetes resolution, LAGB is much easier to perform, has significantly lower mortality and is cheaper. It is therefore important to explore mechanisms to improve LAGB success. The extra impact on weight loss and metabolism achieved by other surgical procedures is suspected to be due to post-operative hormonal changes, including increased glucagon-like-peptide-1 (GLP-1) secretion, not observed following LAGB. Liraglutide (Victosa, Novo Nordisk) is a GLP-1 analogue associated with significant reductions in weight and fasting glucose levels, with good safety and tolerability. The combination of liraglutide and LAGB is likely to offer extremely obese patients with diabetes the opportunity of achieving significant weight loss and diabetes resolution with minimal surgical risk. A total of 200 adult obese patients with T2DM undergoing LAGB will be recruited and post-operatively randomised to one of two groups: liraglutide and placebo. Patients will receive liraglutide or placebo over 6 months. Key assessments (including body composition, oral glucose tolerance tests, quality of life and resting energy expenditure) will be conducted at baseline (pre-operative), as well as 3, 6, 9 and 12 months (post-operative). Data will be analysed to determine the impact of LAGB plus liraglutide on diabetes control.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  11/SW/0106

• Date of REC Opinion

  29 Jun 2011

• REC opinion

  Further Information Favourable Opinion