Health Condition 1: null- Type II Diabetes Mellitus in patients with a Body Mass Index between 27.5 to 32.5kg per metre square
Conditions
Interventions
Intervention1: Laparoscopic Roux-en-Y Gastric bypass (LRYGBP), Laparoscipic Sleeve Gastrectomy (LSG): n/a
Control Intervention1: Standard Medical Management (SMM): n/a
Sponsors
Max Super Speciality Hospital A unit of Devki Devi Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 30 to 60 years at the time of enrollment. 2. Type II DM present according to standard diagnostic criteria (ADA 2010) for at least 6 months. 3. Body mass Index (BMI) 27.5- 32.5 kg/m². 4. Waist circumference >90 cm if male; >80cm if female. 5. Demonstrated to have inadequate control of diabetes defined as HbA1c >8.0mg/dl 6. Ability to complete the run in for dietary intake and exercise 7. Patients who have given written informed consent 8. 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
Exclusion criteria: 1. Type II DM of more than 10 years duration. 2. Weight loss of more than 9 Kgs in preceding six months. 3. Currently pregnant or planning to become pregnant. 4. Cancer requiring treatment in the past 5 years 5. Active HIV or active tuberculosis 6. CVD event within 6 months prior to enrollment 7. Pulmonary embolus in past 6 months 8. 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 aneurysm or at least 7cm in diameter or aortic aneurysm repair; resting heat rate45 beats per minute or 100 beats per minute; heart transplantation. 9. Serum creatinine 1.4mg/dl(women) or 1.5mg/dl(men) 10. History of PE or DVT within 6 months 11. Abnormal serum free T4 (1.8) or thryrotropin (TSH 5.5) 12. Bilirubin, aspartate amino transferase (AST) or alkaline phosphatase more than thrice the normal. 13. Hospitalization for depression in past 6 months. 14. Travel plans that inhibits full participation 15. History of bariatric surgery, small bowel resection or extensive large bowel resection 16. Chronic treatment with systematic corticosteroids 17. Current diagnosis of schizophrenia, or other psychotic disorder, bipolar disorder, alcohol abuse or substance abuse. 18. Alcoholic or drug addict ( daily consumption of alcohol 60ml in males and 30ml in females) 19. Unstable proliferative retinopathy 20. 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Metabolic parameters 1. HDL levels 2. Triglycerides Levels 3. Waist Circumference 4. % Excess weight lossTimepoint: 2 Years Post Operative | — |
Primary
| Measure | Time frame |
|---|---|
| Normalization of Glycemic levels as evidenced by HbA1c levels of (N 6.5mg/dl) at 1 month, 3 month, 12month, 24 month following Surgery.Timepoint: 2 Years Post Operative | — |
Countries
India
Contacts
Public ContactVandana Soni
Co- Investigator
Outcome results
None listed