A comparative Interventional study to evaluate the role of Laparoscopic Roux-en-Y Gastric bypass (LRYGBP), Laparoscopic Sleeve Gastrectomy (LSG) and Standard Medical Management (SMM) in patients of type II Diabetes Mellitus (DM) and Body Mass Index (BMI) between 27.5-32.5 kg/m^2

Not Applicable

Completed

• Conditions: Health Condition 1: null- Type II Diabetes Mellitus in patients with aBody Mass Index between 27.5 to 32.5kg per metre square

• Registration Number: CTRI/2010/091/002928
• Lead Sponsor: Max Super Speciality Hospital A unit of Devki Devi Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ormalization 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

Secondary Outcome Measures

Name	Time	Method
Metabolic parameters 1. HDL levels 2. Triglycerides Levels 3. Waist Circumference 4. % Excess weight lossTimepoint: 2 Years Post Operative