Comparative Interventional Study to Evaluate the Role of LRYGBP, LSG & SMM
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Age 30 to 60 years at the time of enrollment.
- Type II DM present according to standard diagnostic criteria (ADA 2010) for at least 6 months.
- Body mass Index (BMI) between 27.5 - 32.5 kg / m².
- Waist circumference>90 cm if male; >80cm if female.
- Demonstrated to have inadequate control of diabetes defined as HbA1c >8.0mg/dl
- Patients who have given written informed consent.
- Ability to complete the run in for dietary intake and exercise
- Willingness and ability to comply with the follow up protocol, including returns to the clinical center for visits at 1, 3, 12, 24, months post surgery.
Exclusion Criteria:
- TypeII DM of more than 10 years duration.
- Weight loss of more than 9Kgs in preceding six months.
- Currently pregnant or planning to become pregnant.
- Cancer requiring treatment in the past 5 years
- Active HIV or tuberculosis
- CVD event within 6 months prior to enrollment
- Pulmonary embolus in past 6 months
- CVD manifesting any of the following criteria: unstable angina pectoris or angina pectoris at rest; a history of cardiac arrest; complex ventricular arrhythmia at rest or with exercise; uncontrolled atrial fibrillation(heart rate of 100 beats per minute or more); New York Heart Association Class III or IV congestive her failure; acute myocarditis, pericarditis or hypertrophic myocardiopathy; clinically significant aortic stenosis; left bundle block or cardiac pace maker unless approved by cardiologist, cardiac defibrillator; history of aortic aneurysum or at least 7cm in diameter or aortic aneurysum repair; resting heat rate<45 beats per minute or >100 beats per minute; heart transplantation.
- Serum creatinine >1.4mg/dl(women) or 1.5mg/dl(men)
- History of PE or DVT within 6 months
- Abnormal serum free T4 (>1.8) of thryrotropin (TSH >5.5)
- Bilirubin, aspartate amino transferase (AST) or alkaline phosphatase more than thrice the normal.
- Hospitalization for depression in past 6 months.
- Travel plans that inhibits full participation
- History of bariatric surgery, small bowel resection or extensive large bowel resection
- Chronic treatment with systematic corticosteroids
- Current diagnosis of schizophrenia, or other psychotic disorder, bipolar disorder, alcohol abuse or substance abuse.
- Alcoholic or drug addict ( daily consumption of alcohol >60ml in males and >30ml in females)
- Unstable proliferative retinopathy
- Other medical, psychiatric, or behavioral limitations that in the judgments of the investigators may interfere with study participation or the ability to follow the intervention protocol
Sites / Locations
- Max Institute of Minimal Access Metabolic and Bariatric Surgery
- Max Institute of Minimal Access, Metabolic & Bariatric Surgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
LRYGBP
LSG
SMM
Laparoscopic Roux en Y Gastric by pass surgery will be evaluated for patients of Type II DM with BMI between 27.5-32.5 kg/m2 Laparoscopic RYGB is primarily a restrictive procedure with a small element of malabsorption. Glycosylated Haemoglobin will be used as a parameter to assess the status of Type II Diabetes for these patients to evaluate the effect of the intervention at 1 month, 3 months, 12 months and 24 months post discharge.
Laparoscopic Sleeve Gastrectomy surgery will be evaluated for patients of Type II DM with BMI between 27.5-32.5 kg/m2 Laparoscopic Sleeve Gastrectomy is a pure restrictive procedure. Glycosylated Haemoglobin will be used as a parameter to assess the status of Type II Diabetes for these patients to evaluate the effect of the intervention at 1 month, 3 months, 12 months and 24 months post discharge
Standard Medical Management will be evaluated for patients of Type II DM with BMI between 27.5-32.5 kg/m2 Standard Medical management will be as per the recommendation of ADA 2010 guidelines. Glycosylated Haemoglobin will be used as a parameter to assess the status of Type II Diabetes for these patients 1 month, 3 months, 12 months and 24 months post consult