- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02041234
Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes Versus Best Medical Treatment
Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes vs Best Medical Treatment
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Singapore, Singapore, 768828
- Khoo Teck Puat Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Roux-en-Y Gastric Bypass (RYGB)
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.
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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.
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Active Comparator: Best Medical Treatment
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. |
Incretin analogues: Liraglutide up to 1.8 mg daily
Other Names:
Xenical: Up to 120 mg tds
Other Names:
SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily
Other Names:
Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects achieving HBA1c of 6% without diabetic medication
Time Frame: at 12 month after randomisation
|
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.
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at 12 month after randomisation
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Number of subjects achieving systolic BP <130mm hg without antihypertension medication
Time Frame: 12 months post randomisation
|
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
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number of subjects achieving LDL level of <100mg/dl without lipid lowering medication
Time Frame: 12 months post randomisation
|
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.
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12 months post randomisation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fasting plasma glucose
Time Frame: 12 months after Randomisation
|
Secondary end points include levels of fasting plasma glucose, fasting insulin, C-peptide, lipids, C-reactive protein (CRP), the homeostasis model assessment of insulin resistance (HOMA-IR) index, weight loss, blood pressure, adverse events, changes in medications, serum gut hormones and metabolic hormone levels.
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12 months after Randomisation
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Fasting Insulin
Time Frame: 12 months after radomisation
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Secondary end points include levels of fasting plasma glucose, fasting insulin, C-peptide, lipids, C-reactive protein (CRP), the homeostasis model assessment of insulin resistance (HOMA-IR) index, weight loss, blood pressure, adverse events, changes in medications, serum gut hormones and metabolic hormone levels.
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12 months after radomisation
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serum c-peptide level
Time Frame: 12 months post randomisation
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Secondary end points include levels of fasting plasma glucose, fasting insulin, C-peptide, lipids, C-reactive protein (CRP), the homeostasis model assessment of insulin resistance (HOMA-IR) index, weight loss, blood pressure, adverse events, changes in medications, serum gut hormones and metabolic hormone levels.
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12 months post randomisation
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serum lipid levels
Time Frame: 12 months post randomisation
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Secondary end points include levels of fasting plasma glucose, fasting insulin, C-peptide, lipids, C-reactive protein (CRP), the homeostasis model assessment of insulin resistance (HOMA-IR) index, weight loss, blood pressure, adverse events, changes in medications, serum gut hormones and metabolic hormone levels.
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12 months post randomisation
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C-reactive protein level
Time Frame: 12 months post randolmisation
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Secondary end points include levels of fasting plasma glucose, fasting insulin, C-peptide, lipids, C-reactive protein (CRP), the homeostasis model assessment of insulin resistance (HOMA-IR) index, weight loss, blood pressure, adverse events, changes in medications, serum gut hormones and metabolic hormone levels.
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12 months post randolmisation
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change in medications usage
Time Frame: 12 months post randomisation
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Secondary end points include levels of fasting plasma glucose, fasting insulin, C-peptide, lipids, C-reactive protein (CRP), the homeostasis model assessment of insulin resistance (HOMA-IR) index, weight loss, blood pressure, adverse events, changes in medications, serum gut hormones and metabolic hormone levels.
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12 months post randomisation
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changes in gut hormones levels
Time Frame: 12 months post randomisation
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Secondary end points include levels of fasting plasma glucose, fasting insulin, C-peptide, lipids, C-reactive protein (CRP), the homeostasis model assessment of insulin resistance (HOMA-IR) index, weight loss, blood pressure, adverse events, changes in medications, serum gut hormones and metabolic hormone levels.
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12 months post randomisation
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changes in metabolic hormones level
Time Frame: 12 months post randomisation
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Secondary end points include levels of fasting plasma glucose, fasting insulin, C-peptide, lipids, C-reactive protein (CRP), the homeostasis model assessment of insulin resistance (HOMA-IR) index, weight loss, blood pressure, adverse events, changes in medications, serum gut hormones and metabolic hormone levels.
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12 months post randomisation
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health resource utilisation
Time Frame: 12 months post randomisation
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Secondary end points include levels of fasting plasma glucose, fasting insulin, C-peptide, lipids, C-reactive protein (CRP), the homeostasis model assessment of insulin resistance (HOMA-IR) index, weight loss, blood pressure, adverse events, changes in medications, serum gut hormones and metabolic hormone levels. On medium term follow up, we hope to evaluate the effect of successful DM2 improvement post surgery results in reduced resource utilization in the near term and a similar projected reduction over the long term. |
12 months post randomisation
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HOMA-IR
Time Frame: 12 months post randomisation
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Secondary end points include levels of fasting plasma glucose, fasting insulin, C-peptide, lipids, C-reactive protein (CRP), the homeostasis model assessment of insulin resistance (HOMA-IR) index, weight loss, blood pressure, adverse events, changes in medications, serum gut hormones and metabolic hormone levels.
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12 months post randomisation
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Blood Pressure measurement
Time Frame: 12 months post randomisation
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12 months post randomisation
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number of adverse events
Time Frame: 12 months post randomisaiton
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Secondary end points include levels of fasting plasma glucose, fasting insulin, C-peptide, lipids, C-reactive protein (CRP), the homeostasis model assessment of insulin resistance (HOMA-IR) index, weight loss, blood pressure, adverse events, changes in medications, serum gut hormones and metabolic hormone levels.
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12 months post randomisaiton
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Weight loss
Time Frame: 12 months post randomisation
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Secondary end points include levels of fasting plasma glucose, fasting insulin, C-peptide, lipids, C-reactive protein (CRP), the homeostasis model assessment of insulin resistance (HOMA-IR) index, weight loss, blood pressure, adverse events, changes in medications, serum gut hormones and metabolic hormone levels.
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12 months post randomisation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Su Chi Lim, MBBS, PhD, Khoo Teck Puat Hospital
- Principal Investigator: Anton Cheng, MBBS, Khoo Teck Puat Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Lipid Regulating Agents
- Anti-Obesity Agents
- Liraglutide
- Empagliflozin
- Linagliptin
- Incretins
- Sitagliptin Phosphate
- Sodium-Glucose Transporter 2 Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Canagliflozin
- Orlistat
Other Study ID Numbers
- Bariatric Surgery RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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