Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes Versus Best Medical Treatment
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ClinicalTrials.gov Identifier: NCT02041234 |
Recruitment Status :
Completed
First Posted : January 22, 2014
Last Update Posted : June 23, 2022
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Condition or disease | Intervention/treatment | Phase |
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Type II Diabetes in Subjects BMI 27 to 32 | Procedure: Roux-en-Y Gastric Bypass (RYGB) Drug: Incretin analogues Drug: Xenical Drug: SGLT2 inhibitors Drug: DPP-4 Inhibitors | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes vs Best Medical Treatment |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | December 2020 |
Actual Study Completion Date : | June 2022 |

Arm | Intervention/treatment |
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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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Procedure: 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. |
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. |
Drug: Incretin analogues
Incretin analogues: Liraglutide up to 1.8 mg daily
Other Name: Liraglutide Drug: Xenical Xenical: Up to 120 mg tds
Other Name: Orlistat Drug: SGLT2 inhibitors SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily
Other Names:
Drug: DPP-4 Inhibitors Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily
Other Names:
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- 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.
- 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.
- 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.
- 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.
- Fasting Insulin [ Time Frame: 12 months after radomisation ]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.
- serum c-peptide level [ Time Frame: 12 months post 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.
- serum lipid levels [ Time Frame: 12 months post 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.
- C-reactive protein level [ Time Frame: 12 months post randolmisation ]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.
- change in medications usage [ Time Frame: 12 months post 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.
- changes in gut hormones levels [ Time Frame: 12 months post 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.
- changes in metabolic hormones level [ Time Frame: 12 months post 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.
- health resource utilisation [ Time Frame: 12 months post 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.
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.
- HOMA-IR [ Time Frame: 12 months post 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.
- Blood Pressure measurement [ Time Frame: 12 months post randomisation ]
- number of adverse events [ Time Frame: 12 months post randomisaiton ]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.
- Weight loss [ Time Frame: 12 months post 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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Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041234
Singapore | |
Khoo Teck Puat Hospital | |
Singapore, Singapore, 768828 |
Principal Investigator: | Anton Cheng, MBBS | Khoo Teck Puat Hospital | |
Principal Investigator: | Su Chi Lim, MBBS, PhD | Khoo Teck Puat Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Anton Cheng, Dr Anton Cheng, Khoo Teck Puat Hospital |
ClinicalTrials.gov Identifier: | NCT02041234 |
Other Study ID Numbers: |
Bariatric Surgery RCT |
First Posted: | January 22, 2014 Key Record Dates |
Last Update Posted: | June 23, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Diabetes surgical treatment medical treatment |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Phosphate Liraglutide Empagliflozin Linagliptin Canagliflozin Dipeptidyl-Peptidase IV Inhibitors Sodium-Glucose Transporter 2 Inhibitors |
Orlistat Incretins Hypoglycemic Agents Physiological Effects of Drugs Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Obesity Agents Lipid Regulating Agents |