LONG LIMB-2
Research type
Research Study
Full title
What is the impact of a modified Roux-en-Y-gastric bypass operation on people with type 2 diabetes mellitus? The LONG LIMB-2 double-blinded randomised controlled clinical trial
IRAS ID
279091
Contact name
Alexander Miras
Contact email
Sponsor organisation
Imperial College London
ISRCTN Number
ISRCTN65113000
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The profound improvement in glucose control after Roux-en-Y-gastric bypass (RYGB) has led to the recognition of the intestine as a major player in glucose regulation. The optimal length of each of the three limbs (alimentary, biliopancreatic and common) remains controversial. This is further complicated by the differences in total small intestinal length in humans (ranging between 3.5-10.5 meters).
Anatamical arrangements of RYGB results in three segments or "limbs":
1. "Alimentary limb" through which food enters the small intestine through a gastric pouch (the remnant of the stomach)
2. "Biliopancreatic limb" which includes the bypassed segments of the duodenum (first section of the small intestine) and proximal jejunum (second section) through which the biliopancreatic (bile acids from the gall bladder and pancreatic) secretions flow and
3. "Common limb" in which the food and biliopancreatic secretions mix.
Current evidence supports the hypothesis that a "modified" RYGB with a long alimentary limb and short common limb may optimize glucose control. There have not been any clinical trials comparing "modified" and "standard" RYGB with glucose control as primary outcome. In this study, we propose to recruit 80 patients with type 2 diabetes mellitus (DM) and obesity who are eligible for metabolic surgery and currently on the waiting list for bariatric surgery at Imperial College London Healthcare NHS Trust obesity service. Randomisation will take place intra-operatively in patients with a total small intestinal length <5.5 meters. The surgeon will contact the randomiser who will make the allocation to either "modified" or "standard" RYGB before continuing with the surgery. Research will take place at Imperial College London NHS Trust. Participants will attend 5 visits in total (baseline, day 10, 3, 6 and 12 months post operatively) for anthropometric measurements, blood tests, urine pregnancy test, assessment of number of glucose lowering medications and adverse event profile.REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/1070
Date of REC Opinion
4 Nov 2020
REC opinion
Further Information Favourable Opinion