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

NCT04058730 | Unknown

• 1 other identifier: MAMBS04
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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."

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

  immediately after the surgery upto 2 years

Study Arms (3)

LRYGBP

EXPERIMENTAL

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.

Procedure: Laparoscopic Roux en Y Gastric by pass surgery

LSG

EXPERIMENTAL

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

Procedure: Laparoscopic Sleeve Surgery

SMM

EXPERIMENTAL

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

Other: Standard Medical Management

Interventions

Laparoscopic Roux en Y Gastric by pass surgery PROCEDURE

LRYGBP

Laparoscopic Sleeve Surgery PROCEDURE

LSG

Standard Medical Management OTHER

SMM

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Max Institute of Minimally Access, Metabolic & Bariatric Surgery: lead

Study Sites (2)

Max Institute of Minimal Access Metabolic and Bariatric Surgery

New Delhi, 110017, India

Location

Max Institute of Minimal Access, Metabolic & Bariatric Surgery

New Delhi, 110017, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman- Max Institute of Minimal Access, Metabolic and Bariatric Surgery

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 15, 2019
• Study Start: April 1, 2015
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)