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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 / m²."
The primary objective of the study is to evaluate the role of Laparoscopic Roux-en-Y Gastric bypass(LRYGBP), Laparoscopic Sleeve Gastrectomy (LSG) and Standard medical management in patients of type II diabetes and BMI between 27.5 - 32.5 kg / m²."
- A. Partial Remission
- B. Complete Remission
- C. No Remission
Secondary Objective is to evaluate the role of LRYGB, LSG and SMM on other metabolic disorder parameters like
- Waist Circumference
This is a study comparing the role of LRYGB, LSG and SMM in subjects suffering from Type II diabetes mellitus with BMI between 27.5 - 32.5 kg/m². Diabetic patients shall be enrolled as per the inclusion and exclusion criteria. The study treatment will be LRYGB surgery or LSG or SMM in subjects who qualify the inclusion/ exclusion criteria.
Post discharge the study subjects will be followed up at the following intervals:
1 Month, 3 Months 12 Months and 24 Months respectively At follow up subjects shall have an overall clinical examination, adverse events and complication shall be recorded and blood samples for laboratory investigation shall be collected.
Number of Subjects
Planned: 150 qualified subjects
To be Analyzed: 150 qualified subjects
Study Population Male and female subjects 30-60 years of age with Type II Diabetes and BMI between 27.5 - 32.5 kg/m2, who fulfill all the inclusion criteria and do not meet any exclusion criteria will be enrolled into the Study.
Sample Size In this study 150 eligible subjects will be enrolled. One Fifty subjects enrolled would provide the 95% of confidence interval with 10% absolute precision.
Statistical Analysis In this study first normality of the data will be checked. Normally distributed data will be analysed by paired t-test. For non- parametric data Wilcox-on signed rank sum test will be used.
As same Subject will be examined at different time points (more than two time points) the ANOVA of Repeated measures will be used. All tests will be two-tailed and the significance level will be 0.05
Type 2 Diabetes Mellitus
Laparoscopic Roux en Y Gastric by pass surgery, Laparoscopic Sleeve Surgery, Standard Medical Management
Max Institute of Minimal Access Metabolic and Bariatric Surgery
Active, not recruiting
Max Institute of Minimally Access, Metabolic & Bariatric Surgery
Published on BioPortfolio: 2019-08-19T19:46:25-0400
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