Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes Versus Best Medical Treatment

NCT02041234 | Completed Phase 4

• 1 other identifier: Bariatric Surgery RCT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type II Diabetes in Subjects BMI 27 to 32

Keywords

Diabetes; surgical treatment; medical treatment

Outcome Measures

Primary Outcomes (3)

• Number of subjects achieving HBA1c of 6% without diabetic medication

  The primary endpoint is to compare Roux-en-Y Gastric Bypass (RYGB) vs best medical treatment for Asian subjects of BMI 27-32 with poorly controlled type 2 Diabetes (DM2) in achieving a glycated haemoglobin level of 6% or less at 12 months after randomisation, and beyond till the end of the study period, without diabetic medications; and also systolic Blood Pressure of \<130 mm HG, and LDL of \<100mg/dl.

  at 12 month after randomisation

• Number of subjects achieving systolic BP <130mm hg without antihypertension medication

  The primary endpoint is to compare Roux-en-Y Gastric Bypass (RYGB) vs best medical treatment for Asian subjects of BMI 27-32 with poorly controlled type 2 Diabetes (DM2) in achieving a glycated haemoglobin level of 6% or less at 12 months after randomisation, and beyond till the end of the study period, without diabetic medications; and also systolic Blood Pressure of \<130 mm HG, and LDL of \<100mg/dl.

  12 months post randomisation

• number of subjects achieving LDL level of <100mg/dl without lipid lowering medication

  The primary endpoint is to compare Roux-en-Y Gastric Bypass (RYGB) vs best medical treatment for Asian subjects of BMI 27-32 with poorly controlled type 2 Diabetes (DM2) in achieving a glycated haemoglobin level of 6% or less at 12 months after randomisation, and beyond till the end of the study period, without diabetic medications; and also systolic Blood Pressure of \<130 mm HG, and LDL of \<100mg/dl.

  12 months post randomisation

Secondary Outcomes (13)

• fasting plasma glucose

  12 months after Randomisation

• Fasting Insulin

  12 months after radomisation

• serum c-peptide level

  12 months post randomisation

• serum lipid levels

  12 months post randomisation

• C-reactive protein level

  12 months post randolmisation

Study Arms (2)

Roux-en-Y Gastric Bypass (RYGB)

ACTIVE COMPARATOR

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.

Procedure: Roux-en-Y Gastric Bypass (RYGB)

Best Medical Treatment

ACTIVE COMPARATOR

Anti-diabetic medications provided (Mono- or Combination- therapy): Incretin analogues: Liraglutide up to 3 mg daily Or DPP-4 Inhibitors: Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily Xenical: Up to 120 mg tds SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily Participants will also take lipids \& BP medications according to standard of care.

Drug: Incretin analogues; Drug: Xenical; Drug: SGLT2 inhibitors; Drug: DPP-4 Inhibitors

Interventions

Roux-en-Y Gastric Bypass (RYGB) PROCEDURE

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.

Roux-en-Y Gastric Bypass (RYGB)

Incretin analogues DRUG

Incretin analogues: Liraglutide up to 1.8 mg daily

Also known as: Liraglutide

Best Medical Treatment

Xenical DRUG

Xenical: Up to 120 mg tds

Also known as: Orlistat

Best Medical Treatment

SGLT2 inhibitors DRUG

SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily

Also known as: Empagliflozin, Canagliflozin

Best Medical Treatment

DPP-4 Inhibitors DRUG

Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily

Also known as: Sitagliptin, Linagliptin

Best Medical Treatment

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of DM2 = or \< 10 years
• Age 21-65
• BMI 27-32.
• HBA1c ≥ 8%, on maximum treatment from primary care physician
• At least one of the following co-morbidities on treatment: hypertension, hyperlipidaemia, micro/macro-proteinuria or ≤class I nephropathy, retinopathy.

You may not qualify if:

• Subjects who had previous Bariatric surgery or extensive upper abdominal surgery
• Pregnant subjects.
• Nephropathy requiring dialysis
• Subjects who are not fit for general anaesthesia.
• Subjects who are unsuitable for RYGB for whatever reason, medical/surgical/psychological.
• Subjects who are unwilling or possibly unable to participate in the follow up process.
• Subjects who are reluctant to be randomised into the two study groups.
• Subjects who suffers from unstable psychiatric illness
• Subjects who are active substance abusers
• Glutamic acid decarboxylase antibody positive.
• fasting C-peptide \< 300 pmol/L

Sponsors & Collaborators

• Khoo Teck Puat Hospital: lead

Study Sites (1)

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

Location

Related Publications (9)

• Colquitt JL, Picot J, Loveman E, Clegg AJ. Surgery for obesity. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003641. doi: 10.1002/14651858.CD003641.pub3.

  PMID: 19370590 BACKGROUND

• Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.

  PMID: 19272486 BACKGROUND

• Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.

  PMID: 17715408 BACKGROUND

• Dixon JB, Zimmet P, Alberti KG, Rubino F; International Diabetes Federation Taskforce on Epidemiology and Prevention. Bariatric surgery: an IDF statement for obese Type 2 diabetes. Diabet Med. 2011 Jun;28(6):628-42. doi: 10.1111/j.1464-5491.2011.03306.x.

  PMID: 21480973 BACKGROUND

• Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. doi: 10.1097/00000658-199509000-00011.

  PMID: 7677463 BACKGROUND

• Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.

  PMID: 22449319 BACKGROUND

• Mingrone G, Panunzi S, De Gaetano A, Guidone C, Iaconelli A, Leccesi L, Nanni G, Pomp A, Castagneto M, Ghirlanda G, Rubino F. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012 Apr 26;366(17):1577-85. doi: 10.1056/NEJMoa1200111. Epub 2012 Mar 26.

  PMID: 22449317 BACKGROUND

• Cohen RV, Pinheiro JC, Schiavon CA, Salles JE, Wajchenberg BL, Cummings DE. Effects of gastric bypass surgery in patients with type 2 diabetes and only mild obesity. Diabetes Care. 2012 Jul;35(7):1420-8. doi: 10.2337/dc11-2289.

  PMID: 22723580 BACKGROUND

• Cheng A, Yeoh E, Moh A, Low S, Tan CH, Lam B, Sum CF, Subramaniam T, Lim SC. Roux-en-Y gastric bypass versus best medical treatment for type 2 diabetes mellitus in adults with body mass index between 27 and 32 kg/m2: A 5-year randomized controlled trial. Diabetes Res Clin Pract. 2022 Jun;188:109900. doi: 10.1016/j.diabres.2022.109900. Epub 2022 May 2.

  PMID: 35513159 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Gastric Bypass; Liraglutide; Orlistat; Sodium-Glucose Transporter 2 Inhibitors; empagliflozin; Canagliflozin; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate; Linagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Lactones; Organic Chemicals; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Protease Inhibitors; Enzyme Inhibitors; Triazoles; Azoles; Pyrazines; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinazolines

Study Officials

• Anton Cheng, MBBS

  Khoo Teck Puat Hospital

  PRINCIPAL INVESTIGATOR

• Su Chi Lim, MBBS, PhD

  Khoo Teck Puat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Anton Cheng

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 22, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)