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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Khoo Teck Puat Hospital
Sponsor:
Information provided by (Responsible Party):
Anton Cheng, Khoo Teck Puat Hospital
ClinicalTrials.gov Identifier:
NCT02041234
First received: January 10, 2014
Last updated: January 20, 2014
Last verified: January 2014

January 10, 2014
January 20, 2014
February 2014
March 2017   (final data collection date for primary outcome measure)
  • Number of subjects achieving HBA1c of 6% without diabetic medication [ Time Frame: at 12 month after randomisation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT02041234 on ClinicalTrials.gov Archive Site
  • fasting plasma glucose [ Time Frame: 12 months after Randomisation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • number of adverse events [ Time Frame: 12 months post randomisaiton ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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

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.

20 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type II Diabetes in the Not so Obese
  • 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.
  • Drug: Incretin analogues
    Incretin analogues: Liraglutide up to 1.8 mg daily If unable to take incretin analogues: Januvia up to 100 mg daily
    Other Name: Liraglutide
  • Drug: Xenical
    Xenical: Up to 120 mg tds
  • 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.
    Intervention: Procedure: Roux-en-Y Gastric Bypass (RYGB)
  • Active Comparator: Incretin analogues and Xenical
    Incretin analogues: Liraglutide up to 1.8 mg daily. If unable to take incretin analogues: Januvia up to 100 mg daily. Xenical: Up to 120 mg tds. Participants will also take lipids & BP medications according to standard of care.
    Interventions:
    • Drug: Incretin analogues
    • Drug: Xenical

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
March 2017
March 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Established diagnosis of DM2 = or < 5 years
  2. Age 25-65
  3. BMI 27-32.
  4. HBA1c = 8%, on insulin treatment.or starting on insulin/incretin analogs
  5. At least one of the following co-morbidities on treatment: hypertension, hyperlipidaemia, micro/macro-proteinuria or =class I nephropathy, retinopathy, ischaemic heart disease.

Exclusion Criteria:

  1. Subjects who had previous Bariatric surgery or extensive upper abdominal surgery
  2. Pregnant subjects.
  3. Nephropathy requiring dialysis
  4. Subjects who are not fit for general anaesthesia.
  5. Subjects who are unsuitable for RYGB for whatever reason, medical/surgical/psychological.
  6. Subjects who are unwilling or possibly unable to participate in the follow up process.
  7. Subjects who are reluctant to be randomised into the two study groups.
  8. Subjects who suffers from unstable psychiatric illness
  9. Subjects who are active substance abusers
  10. Glutamic acid decarboxylase antibody positive.
  11. fasting C-peptide < 300 nM
Both
25 Years to 65 Years
No
Contact: Anton Cheng, MBBS 6602 3305 cheng.anton.ks@alexandrahealth.com.sg
Contact: Boon Khim Lim 6602 3307 lim.boon.khim@alexandrahealth.com.sg
Singapore
 
NCT02041234
Bariatric Surgery RCT
No
Anton Cheng, Khoo Teck Puat Hospital
Khoo Teck Puat Hospital
Not Provided
Principal Investigator: Anton Cheng, MBBS Khoo Teck Puat Hospital
Principal Investigator: Su Chi Lim, MBBS, PhD Khoo Teck Puat Hospital
Khoo Teck Puat Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP