FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2010/091/002814 [Registered on: 18/10/2010]
Last Modified On: 19/09/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Surgical/Anesthesia
Other (Specify) [Surgical (RYGB) versus Medical Management]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  
COSMID Trial (Comparison of Surgery vs. Medicine for Indian Diabetes) 
Scientific Title of Study
Modification(s)  
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). 
Trial Acronym  COSMID 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2010/GBP/LOC/004  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Shashank Shah 
Designation  Laparoscopic and Bariatric Surgeon 
Affiliation   
Address  1st Floor, Cancer Building, OPD No 104, Laparo Obeso Division
Ruby Hall Clinic, 40 Sassoon Road
Pune
MAHARASHTRA
411001
India 
Phone  91-9822026734  
Fax  91-20-66455563  
Email  drshashanks@gmail.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Shashank Shah 
Designation  Consultant Laproscopic and Bariatric Surgeon 
Affiliation   
Address  First Floor Cancer Building OPD No 104 Laparo Obeso Division Ruby Hall Clinic
Ruby Hall Clinic 40 Sassoon Road
Pune
MAHARASHTRA
411001
India 
Phone  919822026734  
Fax  91-20-66455563  
Email  drshashanks@gmail.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Jayashree Todkar 
Designation  Consultant Laproscopic and Bariatric Surgeon 
Affiliation   
Address  1st Floor Cancer Building OPD No 104 Laparo Obeso Division
Ruby Hall Clinic 40 Sassoon Road
Pune
MAHARASHTRA
411001
India 
Phone  91-9823090505  
Fax  91-20-66455563  
Email  jayatodkar@hotmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Funding Source Ethicon Endo-Surgery, Inc. A Johnson & Johnson Company Attn: Robin Scamuffa, Director Clinical Affairs 4545 Creek Road Cincinnati, Ohio 45242-2839, USA Phone: 001 513-337-7630 Email: rscamuff@its.jnj.com  
 
Primary Sponsor
Modification(s)  
Name  Ruby Hall Clinical Services Limited  
Address  40 Sassoon Road Pune India 411001 Phone 91-20-26123391 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
NIL  NIL 
 
Countries of Recruitment
Modification(s)  
  India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shashank Shah   Ruby Hall Clinic  1st Floor Cancer Building OPD No 104 Laparo Obeso Division 40 Sassoon Road 411001
Pune
MAHARASHTRA 
919822026734

drshashanks@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Poona Medical Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Type 2 Diabetes Mellitus,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Gastric Bypass Surgery   
Comparator Agent  Medical Arm  Optimal Medicinal (Diabetic) and Lifestyle Management 
 
Inclusion Criteria
Modification(s)  
Age From  25.00 Day(s)
Age To  65.00 Day(s)
Gender  Both 
Details  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  
 
ExclusionCriteria 
Details  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&#8223;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 
 
Method of Generating Random Sequence
Modification(s)  
Stratified block randomization 
Method of Concealment
Modification(s)  
Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking
Modification(s)  
Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Primary Endpoint:
1. Change in Diabetes Status: Percent achieving disease remission

Also noted: glycemia Controlled, Improved, Unchanged, Worsened

2. Treatment Safety
 
1 and 2 years 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
The Tertiary Endpoints will include: (a)changes in diabetes-specific co-morbidities and associated medication requirements and dosage; (b) changes in quality of life.  2 years 
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.  1 and 2 years 
 
Target Sample Size
Modification(s)  
Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial
Modification(s)  
N/A 
Date of First Enrollment (India)
Modification(s)  
19/04/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/04/2011 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial
Modification(s)  
Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  
Study ongoing. No publication yet.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
COSMID Brief Summary: A prospective, randomized, parallel-group, single center clinical trial under an intention-to-treat principle to compare the impact of RYGB (plus medical therapy as needed) vs. optimal medical and lifestyle management alone among Asian Indian adults with T2DM and a BMI between 25 and 40 kg/m2. Eighty adults with T2DM will be randomly assigned in a 1:1 ratio to one of two treatment groups, The treatment groups will be: (1) laparoscopic RYGB surgery or (2) Optimal Medical Management and Lifestyle Changes in diabetes status and associated co-morbidities, mechanisms underlying improvement or deterioration of diabetes status and complications will be followed over the course of two years following surgery or optimal medical and lifestyle management. The Primary Endpoint of the study will be treatment-induced changes in diabetes status ? specifically, the percentage of patients in each group who experience durable diabetes remission at one year, although other diabetes outcomes will also be recorded (i.e., improvement vs. no change vs. worsening of glycemic control). We will also carefully monitor and record the safety (i.e., adverse events) of each intervention. 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. The Tertiary Endpoints will include: (a) changes in diabetes-specific co-morbidities and associated medication requirements and dosage; (b) changes in quality of life. 
Close