Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes Versus Best Medical Treatment
Condition: Type II Diabetes in Subjects BMI 27 to 32
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigators aim to show that Roux-en-Y Gastric Bypass (RYGB) is superior to best medical
      treatment in reaching well-defined treatment end points in Asian subjects of BMI 27-32 with
      type 2 Diabetes (DM2). Investigators also hope to show that successful RYGB will reduce
      resource utilization in the near term with similar projected reduction over the medium to
      long term.
    

Detailed description: 
      40 subjects with DM2 will be recruited, randomised into two arms. The surgical arm will be
      subjected to RYGB. The medical arm will be treated maximally utilising the best means
      available and following internationally available protocol/guidelines. The study population
      will be subjected to a set of tests which is over and above the standard tests for similar
      groups of patients undergoing standard care (details below). Some test samples will be
      bio-banked. Treatment end points and follow up protocol will be the same for each treatment
      arm. The International Diabetic Federation (IDF) in 2011 recommended that bariatric surgery
      should be considered an alternative treatment option for those Asian DM2 subjects with BMI of
      27 or above. Data for the effectiveness of Bariatric Surgery for those DM subjects with lower
      BMI is not as well established as those with higher BMI. There is scant good quality data,
      especially from Asian subjects. As their treatment is totally funded by the research project,
      subjects on the non surgical treatment arm will benefit from the more intense management of
      their disease with no restriction due to cost. The surgical arm will also be fully funded by
      the research project. They will be exposed to the standard risks associated with this type of
      surgery. Subjects in both arms will have to provide more blood and other samples than usual
      and has to follow visits protocol as close as possible. RYGB is a major surgical procedure,
      with significant potential complications; during the process of surgery and afterwards, both
      short and long term. Procedure related mortality is about 0.3%. Major complications that may
      require surgical intervention includes: anastomotic leakage about 3-4%, bleeding 3%,
      infection 3%, venous thrombo-embolism 1%. Some of these complications will require prolong
      hospitalisation. After surgery, loose stool, dumping syndrome, anastomotic ulcers can occur
      in less than 3%.Life long dietary supplement will be required. Longer term post surgical
      complications include intestinal obstruction due to adhesions or internal hernia, about 2%,
      further surgery may be needed. This risk is lifelong. Nutritional deficiencies, especially if
      not compliant with regular supplement intake, may occur. Drug allergies can occur; from
      simple rash to life threatening anaphylactic reaction. Blood taking can cause bruising, pain
      at the puncture site and sometimes fainting.
    

Intervention name(s): Roux-en-Y Gastric Bypass (RYGB); Incretin analogues; Xenical; SGLT2 inhibitors; DPP-4 Inhibitors
Intervention type(s): Procedure; Drug; Drug; Drug; Drug
Intervention description(s): Roux-en-Y Gastric Bypass (RYGB) as per standard surgical protocol, with a 30 cc gastric pouch, 50 cm biliopancreatic limb and 100cm gastrointestinal limb.; Incretin analogues: Liraglutide up to 1.8 mg daily; Xenical: Up to 120 mg tds; SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily; Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily
Other intervention name(s): Liraglutide; Orlistat; Empagliflozin; Canagliflozin; Sitagliptin; Linagliptin
Intervention MeSH terms: Sitagliptin Phosphate; Liraglutide; Empagliflozin; Linagliptin; Canagliflozin; Dipeptidyl-Peptidase IV Inhibitors; Sodium-Glucose Transporter 2 Inhibitors; Orlistat; Incretins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; surgical treatment; medical treatment