Clinical trial NCT02041234: Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes Versus Best Medical Treatment
Official title: Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes vs Best Medical Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type II Diabetes in Subjects BMI 27 to 32
Keywords: Diabetes
surgical treatment
medical treatment
Lead sponsor: Khoo Teck Puat Hospital
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

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 pmol/L

Primary outcomes:
measure: Number of subjects achieving HBA1c of 6% without diabetic medication
timeFrame: at 12 month after randomisation
measure: Number of subjects achieving systolic BP <130mm hg without antihypertension medication
timeFrame: 12 months post randomisation
measure: number of subjects achieving LDL level of <100mg/dl without lipid lowering medication
timeFrame: 12 months post randomisation
Secondary outcomes:
measure: fasting plasma glucose
timeFrame: 12 months after Randomisation
measure: Fasting Insulin
timeFrame: 12 months after radomisation
measure: serum c-peptide level
timeFrame: 12 months post randomisation
measure: serum lipid levels
timeFrame: 12 months post randomisation
measure: C-reactive protein level
timeFrame: 12 months post randolmisation
measure: change in medications usage
timeFrame: 12 months post randomisation
measure: changes in gut hormones levels
timeFrame: 12 months post randomisation
measure: changes in metabolic hormones level
timeFrame: 12 months post randomisation
measure: health resource utilisation
timeFrame: 12 months post randomisation
measure: HOMA-IR
timeFrame: 12 months post randomisation
measure: Blood Pressure measurement
timeFrame: 12 months post randomisation
measure: number of adverse events
timeFrame: 12 months post randomisaiton
measure: Weight loss
timeFrame: 12 months post randomisation
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
Study officials:
affiliation: Khoo Teck Puat Hospital
name: Anton Cheng, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Khoo Teck Puat Hospital
name: Su Chi Lim, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: 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.