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."
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Glycosylated Haemoglobin less than 6.5 mg/dl
研究概览
简要总结
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."
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Glycosylated Haemoglobin less than 6.5 mg/dl
时间窗: immediately after the surgery upto 2 years
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
次要结局
未报告次要终点
研究者
DR PRADEEP CHOWBEY
Chairman- Max Institute of Minimal Access, Metabolic and Bariatric Surgery
Max Institute of Minimally Access, Metabolic & Bariatric Surgery