Single Anastomosis Duodeno Jejunal Bypass With Sleeve Gastrectomy (SADJB-SG) Versus Intensive Medical Therapy (IMT) in the Treatment of Type 2 Diabetes Mellitus Among Asian Patients With BMI 23.5 - 30 kg/m2: A Clinical Trial

Recruitment will be a prospective study in patients with body mass index (BMI) of 23.5-30 kg/m2, aged between 18 and 65 years old. Each patient will be preoperatively screened (including psychologist assessment) and evaluated by the study multidisciplinary team before recruitment. The study will involve two groups with equal allocation of patients in the intensive medical therapy (IMT) group and Single Anastomosis Duodeno Jejunal Bypass with Sleeve Gastrectomy (SADJB-SG) group with stratification by use of insulin at screening. All patients who agree to participate in this study will be assigned to one of the treatment groups by the doctor without randomization. Before making a final decision for treatment, every patient will undergo a detailed and up-to-date evaluation by the doctor regarding the suitability, the pros and cons, risk and benefits, the potential postoperative complications and the likelihood of requiring postoperative nutritional supplementation. Patients that are eligible to take part in this study will be informed, and the final decision will solely be made based on patients' willingness. The patients will also be made aware that this is an experimental trial and both verbal and written informed consent will be taken before treatment. In addition, the patients will be informed regarding the use of the clinical and analytical data for publication purposes. Initial assessment of the patient's social demographic data, history of present illness (duration of diabetes, oral hypoglycemic agent used), medical and surgical history, family history, anthropometric measurements (height, weight, BMI, calculated as weight (kg)/height (m2), waist, hip and neck circumference), history of weight loss attempt, diet and lifestyle assessment, quality of life assessment and biochemical measures including fasting blood glucose (FBG), glycated haemoglobin (HbA1c), C- peptide, plasma insulin and HOMA-IR, assessment for obstructive sleep apnea, depression and sleep quality will be obtained upon approval of participation in the study or before any form of treatment. An additional pre-operation questionnaire will be given to the SADJB-SG group during initial assessment to ensure understanding of the patients towards the surgery. Adverse events will be monitored closely at 1, 2, 3, and 4 weeks after surgery. In any occurrence of an adverse event, it will be documented and reported within 14 days.The study will be terminated if there are life-threatening or severe adverse events associated with SADJB-SG group or IMT group.

Patients will not be given access to the study data however the patients will be informed regarding their progress during every follow-up visit. All medical records and research data will be kept in the investigator's hard disk and web-based storage (i-cloud and i-drive) for two years. Study data will be held even after the study period as there will still be a continuous follow-up with the patients for life. However, all patients' information obtained from this study will be kept and handled in a confidential manner, by applicable laws and regulations. When publishing or presenting the study results, the identity of patients will not be revealed without patient's expressed consent. Participants will also be covered under clinical trial insurance from the institution during the study period. In the case of emergency, all patients will be given the contact number of the investigator as the investigators are contactable throughout the day. This study will begin after receiving the approval of Medical Research & Ethics Committee, Ministry of Health Malaysia.

Sample size:

The sample size was estimated with the help of PS software (power and sample size calculation software) 3.1.2 with a power of 80% and a significant level of 0.05. The estimation was based on the diabetic remission in a few study done on bariatric surgery on one arm and intensive medical treatment on the other and it was detected a range of 57% to 73% diabetic remission among the bariatric surgery group. Another study by Lee WJ et al., 2014 found a diabetic remission rate of 64% (HbA1C<6.0%) with the SADJB-SG group one year after surgery. The total estimated sample size is 34 patients in each arm for this study. However, with the inclusion of 20% dropout rate, the total number of patients needed for this study is 42 patients in each arm.

Laboratory investigations: