COSMID Trial (Comparison of Surgery vs. Medicine for Indian Diabetes)
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2010/091/002814
- Lead Sponsor
- Ruby Hall Clinical Services Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint: <br/ ><br>1.Change in Diabetes Status: Percent achieving disease remission <br/ ><br> <br/ ><br>Also noted: glycemia Controlled, Improved, Unchanged, Worsened <br/ ><br> <br/ ><br>2. Treatment Safety <br/ ><br>Timepoint: 1 and 2 years
- Secondary Outcome Measures
Name Time Method The Secondary Endpoints: will be determined in a subpopulation of 20 patients per treatment group to identify mechanisms underlying changes in glycemic control following surgery or medical & lifestyle management: (a) changes in insulin sensitivity and secretion; (b) changes in body weight, whole-body and regional body-fat depot size; and (c) changes in gut hormones that affect glucose homeostasis.Timepoint: 1 and 2 years;The Tertiary Endpoints will include: (a)changes in diabetes-specific co-morbidities and associated medication requirements and dosage; <br>(b) changes in quality of life.Timepoint: 2 years