Comparative Interventional Study to Evaluate the Role of LRYGBP, LSG & SMM

Type 2 Diabetes Mellitus Clinical Trial

Official title: A Comparative Interventional Study to Evaluate the Role of LRYGBP, LSG and SMM in Patients of Type II DM and BMI Between 27.5 - 32.5 kg / m²."

Status Active, not recruiting

Clinical Trial Summary

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."

Clinical Trial Description

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

• Dyslipidemia

• Hypertension

• 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

Statistical Methods:

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 ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT04058730
• Study type: Interventional
• Source: Max Institute of Minimally Access, Metabolic & Bariatric Surgery
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2015
• Completion date: December 2021