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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Laparoscopic Roux en Y Gastric by pass surgery

Laparoscopic Sleeve Surgery

Standard Medical Management

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

LRYGBP

LSG

SMM

Arm Description

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

Outcomes

Primary Outcome Measures

Glycosylated Haemoglobin less than 6.5 mg/dl

The remission of Type II Diabetes Mellitus will be assessed on the basis of the Glycosylated Haemoglobin levels of the patient post surgery.. At 1 month, 3months, 12months, 24 months after discharge

Secondary Outcome Measures

Full Information

NCT ID

NCT04058730

First Posted

August 20, 2018

Last Updated

September 3, 2021

Sponsor

Max Institute of Minimally Access, Metabolic & Bariatric Surgery

1. Study Identification

Unique Protocol Identification Number

NCT04058730

Brief Title

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

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."

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2015 (Actual)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Max Institute of Minimally Access, Metabolic & Bariatric Surgery

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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."

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LRYGBP

Arm Type

Experimental

Arm Description

Arm Title

LSG

Arm Type

Experimental

Arm Description

Arm Title

SMM

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic Roux en Y Gastric by pass surgery

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic Sleeve Surgery

Intervention Type

Other

Intervention Name(s)

Standard Medical Management

Primary Outcome Measure Information:

Title

Glycosylated Haemoglobin less than 6.5 mg/dl

Description

The remission of Type II Diabetes Mellitus will be assessed on the basis of the Glycosylated Haemoglobin levels of the patient post surgery.. At 1 month, 3months, 12months, 24 months after discharge

Time Frame

immediately after the surgery upto 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Max Institute of Minimal Access Metabolic and Bariatric Surgery

City

New Delhi

ZIP/Postal Code

110017

Country

India

Facility Name

Max Institute of Minimal Access, Metabolic & Bariatric Surgery

City

New Delhi

ZIP/Postal Code

110017

Country

India

12. IPD Sharing Statement

Plan to Share IPD

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

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