CTRI/2010/091/002814进行中（未招募）未知
A prospective randomized parallel-group trial of the effectiveness and safety of gastric bypass surgery vs. optimal medical/lifestyle management of type 2 diabetes among Asian Indians with mild to moderate obesity (i.e., body mass index 25 to 40 kg/m2). - COSMID
Ruby Hall Clinical Services Limited0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •a) Diagnosed T2DM, taking insulin at any dose or at least one oral anti-diabetes medication at least half-maximum dose for >6 months; HbA1c >7.0% OR: Documented T2DM (i.e. based on a prior fasting blood glucose >126 mg/dL or a random or 2-hour 75-g OGTT-challenged glucose >200 mg/dL or HbA1c >7.0%), taking insulin at any dose or at least one oral anti-diabetes medication at least half-maximum dose for >6 months; HbA1c >7.0% b) Age 25 to 65 years c) BMI 25 to 40 kg/m2 (i.e., meeting the Asian Indian-specific definition of obesity) d) Waist circumference >90 cm for males or >80 cm for females (i.e., meeting the Asian Indian-specific definition of obesity) e) Agree to randomization and terms of the study f) Ethnic South-Asian Indian, as judged by the investigators g) Plan to stay within the region for a period of at least two years after initiation of the study h) Competent to provide informed consent, as judged by the investigators i) Willing to adhere to all elements of the protocol, including signing the informed consent document
排除标准
- •a) Prior bariatric surgery, gastrectomy, or bowel resection (not including appendectomy COSMID Trial Shah Study Code: 2010/GBP/LOC/004 8/3/2010 Shah, Kim, Cummings et al. 19 CONFIDENTIAL b) C-peptide level <1.0 ng/mL after overnight fasting, and increases at 2 hours after a test meal c) Anti-glutamic acid decarboxylase (GAD65) antibodies positive d) Anti-IA2 antibodies positive e) Diabetes diagnosed prior to 25 years of age f) Family or personal history of maturity-onset diabetes of the young g) History of chronic or idiopathic acute pancreatitis h) Diabetes occurring secondary to pancreatic injury, acromegaly, or Cushings syndrome i) American Society of Anesthesiology (ASA) physical classification score of 4 or above j) Chronic active hepatitis, cirrhosis, inflammatory bowel disease, severe pulmonary disease k) Receipt of any investigational drug within one month prior to study l) Failure to receive psychological clearance for laparoscopic RYGB by the mental health team at the study center m) Active drug or alcohol addiction n) Current malignancy except non-melanoma skin cancer o) Major cardiovascular event within the past 6 months (myocardial infarction, coronary artery bypass surgery, angioplasty, stroke, pulmonary embolus, documented transient ischemic attack). p) Prior transplantation of any major organ (heart, lung, liver, kidney)q) Pregnancy (as determined by a pregnancy test at baseline) or a sexually active premenopausal female who does not agree to use contraception for the duration of the study r) Duration of diagnosed T2DM >15 years s) Any concurrent medical condition/disorder that, in the opinion of the investigator, is likely to interfere with the patient‟s ability to participate in all aspects of the trial (in either arm) or to require, during the study, the administration of a treatment that would affect the interpretation of study results
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