CTRI/2010/091/002928
Completed
未知
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/m^2
Max Super Speciality Hospital A unit of Devki Devi Foundation0 sites150 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Type II Diabetes Mellitus in patients with aBody Mass Index between 27.5 to 32.5kg per metre square
- Sponsor
- Max Super Speciality Hospital A unit of Devki Devi Foundation
- Enrollment
- 150
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age 30 to 60 years at the time of enrollment.
- •2\.Type II DM present according to standard diagnostic criteria (ADA 2010\) for at least 6 months.
- •3\.Body mass Index (BMI) 27\.5\- 32\.5 kg/m².
- •4\.Waist circumference \>90 cm if male; \>80cm if female.
- •5\.Demonstrated to have inadequate control of diabetes defined as HbA1c \>8\.0mg/dl
- •6\.Ability to complete the run in for dietary intake and exercise
- •7\.Patients who have given written informed consent
- •8\.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
- •1\.Type II DM of more than 10 years duration.
- •2\.Weight loss of more than 9 Kgs in preceding six months.
- •3\.Currently pregnant or planning to become pregnant.
- •4\.Cancer requiring treatment in the past 5 years
- •5\.Active HIV or active tuberculosis
- •6\.CVD event within 6 months prior to enrollment
- •7\.Pulmonary embolus in past 6 months
- •8\.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 aneurysm or at least 7cm in diameter or aortic aneurysm repair; resting heat rate45 beats per minute or 100 beats per minute; heart transplantation.
- •9\.Serum creatinine 1\.4mg/dl(women) or 1\.5mg/dl(men)
- •10\.History of PE or DVT within 6 months
Outcomes
Primary Outcomes
Not specified
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