CTRI/2010/091/002928已完成未知
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 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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
- •11.Abnormal serum free T4 (1.8) or thryrotropin (TSH 5.5)
- •12.Bilirubin, aspartate amino transferase (AST) or alkaline phosphatase more than thrice the normal.
- •13.Hospitalization for depression in past 6 months.
- •14.Travel plans that inhibits full participation
- •15.History of bariatric surgery, small bowel resection or extensive large bowel resection
- •16.Chronic treatment with systematic corticosteroids
- •17.Current diagnosis of schizophrenia, or other psychotic disorder, bipolar disorder, alcohol abuse or substance abuse.
- •18.Alcoholic or drug addict ( daily consumption of alcohol 60ml in males and 30ml in females)
- •19.Unstable proliferative retinopathy
- •20.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
研究者
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