REVISE-Diabesity

• Research type

  Research Study

• Full title

  REVISE-Diabesity: Randomisation to Endoluminal intestinal liner alone Versus with Incretin analogue in SustainEd Diabesity

• IRAS ID

  110264

• Contact name

  Bob Ryder

• Sponsor organisation

  Sandwell and West Birmingham Hospitals NHS Trust

• Eudract number

  2012-004988-42

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The pandemic of combined type 2 diabetes (T2DM) and obesity, ??diabesity?? continues unabated. New, effective therapies are urgently needed. Endobarrier is a tube-like liner that coats the inside of the small intestine, allowing food to pass through but not be absorbed. We propose a study that will allow us to describe the place of this novel device, which can improve diabetes and reduce weight, without major surgery in patients failing to achieve treatment targets with current medications. The aim of this randomised controlled clinical trial is to assess, in an NHS setting: i) the effect of Endobarrier in patients with T2DM and obesity, on their weight and glycated haemoglobin (HbA1c, a measure of diabetes control); ii) whether combined Endobarrier-Liraglutide use improves outcomes compared to Endobarrier alone; iii) understand the mechanisms of action of Endobarrier. Patients will be included if their weight and HbA1c levels are suboptimal despite at least 6 months?? treatment with Liraglutide. This is an injectable daily medication for diabetes that mimics glucagon-like peptide-1 (GLP-1 receptor agonist). We will conduct a 24 month clinical trial in 72 patients with T2DM and obesity that have suboptimal weight and HbA1c targets on Liraglutide. They will be randomly allocated to receive either Liraglutide alone at increased dose (controls), Endobarrier alone or Endobarrier with continued Liraglutide. In cases involving Endobarrier insertion, devices will be removed after 12 months. Repeated measures of HbA1c, weight, waist circumference and body mass index will be recorded at 3 monthly intervals. We will also seek to evaluate the mechanisms of action of Endobarrier by measuring i) insulin resistance, often altered in T2DM and calculated by measuring blood glucose and insulin; ii) ??fat?? levels around the liver and pancreas, assessed by magnetic resonance imaging, as these are key organs involved in glucose and insulin secretion, important in T2DM.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  12/WM/0408

• Date of REC Opinion

  2 Jan 2013

• REC opinion

  Further Information Favourable Opinion