Status:
UNKNOWN
Comparative Interventional Study to Evaluate the Role of LRYGBP, LSG & SMM
Lead Sponsor:
Max Institute of Minimally Access, Metabolic & Bariatric Surgery
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-60 years
Phase:
NA
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 Ty...
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 I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04058730
Start Date
April 1 2015
End Date
December 1 2021
Last Update
September 5 2021
Active Locations (2)
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1
Max Institute of Minimal Access Metabolic and Bariatric Surgery
New Delhi, India, 110017
2
Max Institute of Minimal Access, Metabolic & Bariatric Surgery
New Delhi, India, 110017