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Clinical Trial Details (PDF Generation Date :- Fri, 12 Jul 2019 16:24:55 GMT)

CTRI Number CTRI/2012/02/002398 [Registered on: 02/02/2012] - Trial Registered Retrospectively

Last Modified On 31/12/2012
Post Graduate Thesis No
Type of Trial Observational
Type of Study Cross Sectional Study
Study Design Non-randomized, Multiple Arm Trial
Public Title of Study STARCH: Study To Assess the dietaRy CarboHydrate content of Indian diabetic population
Scientific Title of Epidemiological study to evaluate the dietary composition of Indian type-2 diabetic patients
Study compared to non-diabetic population
Secondary IDs if Any Secondary ID Identifier
NN1120IN Protocol Number
Details of Principal Details of Principal Investigator
Investigator or overall
Name DR SHASHANK R JOSHI
Trial Coordinator
(multi-center study) Designation CONSULTANT ENDOCRINE & METABOLIC PHYSICIAN
Affiliation
Address 12, GOLDEN PALACE,BEHIND UNION BANK,TURNER
ROAD,BANDRA WEST,MUMBAI
Mumbai
MAHARASHTRA
400050
India
Phone 9321024941
Fax
Email [email protected]
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Rahul Rathod
Query)
Designation Senior Medical Advisor
Affiliation Bayer Zydus Pharma Private Limited
Address Bayer Zydus Pharma Private Limited I Kolshet Road Thane India
400 607
Thane
MAHARASHTRA
400 607
India
Phone 912225311431
Fax 912225455007
Email [email protected]
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Rahul Rathod
Designation Senior Medical Advisor
Affiliation Bayer Zydus Pharma Private Limited
Address Bayer Zydus Pharma Private Limited I Kolshet Road Thane India
400 607

MAHARASHTRA
400 607
India
Phone 912225311431

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Fax 912225455007
Email [email protected]
Source of Monetary or Source of Monetary or Material Support
Material Support
> BayerZydus Pharma Pvt ltd Kolshet road,Thane - 400 607 Maharashtra
Primary Sponsor Primary Sponsor Details
Name Bayer Pharmaceuticals
Address Bayer Pharma Private Limited, Kolshet Road, Thane, Maharashtra,
India. Pin – 400607
Type of Sponsor Pharmaceutical industry-Global
Details of Secondary Name Address
Sponsor
NA NA
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Dr Mala Dharmalingam Bangalore Dept of 9845208163
Endocrinology & Endcrinology,35, 5th
Diabetes Research Cross, Malleshwaram endocrinology23@rediff
center Circle,Near Biz Bazaar, mail.com
Next to Indian Bank,
Bengaluru 560 003
Bangalore
KARNATAKA
Dr Sarita Bajaj Dr. Sarita Bajaj 3/6,Panna lal road, 9415239392
Allahabad - 211
002,UP,India [email protected]
Allahabad m
UTTAR PRADESH
Dr Subodh Banzal Dr. Subodh Banzal "107,Trade House, Opp 9893693006
Dhakkanwala Kua,
South Tukoganj, [email protected]
INDORE." om
Indore
MADHYA PRADESH
Dr Swapan Sarkar Dr. Swapan Sarkar "Ganraj Chowmuhani, 9436120269
Banamalipur, P.O.
Agartala , Tripura west swapanagt1958@yaho
,PIN: 799007 o.com
North Tripura
TRIPURA
DrR K Sahay Dr.R K Sahay MY NEST"6-3-852/A,A 9849597507
MERPREET
,HYDERABAD - [email protected]
500016
Hyderabad
ANDHRA PRADESH
DrShachin Gupta Dr.Shachin Gupta "8/2,Sanjay complex, 9425010103
Near Mata Mandir,
South T T Nagar shachinseema@yahoo.
Bhopal-462 003" com
Bhopal
MADHYA PRADESH
Dr Parag Shah Gujarat Endocrine 201,2nd floor, Silver 9824042688
Centre Brook-B, Opp. Doctor

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House, Nr. Parimal paragendocrine@yahoo

Crossing, Ellisbridge, .com
Ahmedabad-380006.
Ahmadabad
GUJARAT
DrSatinath Institute of Post 244,AJC Bose 9830027985
Mukhopadhyay Graduate Medical Road,Ronald Ross
Education & Research Building,4th Floor, [email protected]
Room No m
9,Kolkata-700020
Kolkata
WEST BENGAL
Dr Shashank Joshi Joshi Clinic Block 12, Golden 9820186302
Palace, Behind Union
Bank, Turner Road, [email protected]
Bandra (W)- m
Mumbai-400050
Mumbai
MAHARASHTRA
Dr Anil Bansali Post Graduate Institute Department of 9316977995
of Medical Education & Endocrinology
Research Chandiragh-160012 anilbhansali_endocrine
Chandigarh @rediffmail.com
CHANDIGARH
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Bangalore Approved 27/12/2011 No
Endocrinology &
Diabetes Research
center Ethics
Committee on Human
Research ,Bangalore
CLINICOM Bangalore - Approved 25/11/2011 Yes
Dr Banzal
CLINICOM Bangalore - Approved 25/11/2011 Yes
Dr Gupta
CLINICOM Bangalore - Approved 25/11/2011 Yes
DR Sahay
CLINICOM Approved 12/12/2011 Yes
BANGALORE - Dr
Sarkar
CLINICOM Bangalore - Approved 25/11/2011 Yes
Dr Shah
CLINICOM Bangalore - Approved 20/01/2012 Yes
Dr Shashank Joshi
CLINICOM Bangalore Approved 25/11/2011 Yes
-Dr Bajaj
Institute Ethics Approved 23/01/2012 No
Committee Post
Graduate Institiute of
Medical Education &
Research,Chandigarh
IPGME&R Research Approved 13/01/2012 No
Oversight
Committee,IPGMER
Kolkata
Regulatory Clearance

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Status from DCGI Status Date

No Objection Certificate 15/11/2011
Health Condition / Health Type Condition
Problems Studied
Patients Diabetic population and non diabetic populaion
Intervention / Type Name Details
Comparator Agent
Inclusion Criteria Inclusion Criteria
Age From 18.00 Year(s)
Age To 70.00 Year(s)
Gender Both
Details Diabetic Population
Patients willing to provide signed & dated informed consent and
comply with study
Indian diabetic population diagnosed with T2DM for at least 12
months
Male and non pregnant female with age18 years or more
Non-Diabetic Population
Indian non-diabetic population who are not following any diet plan or
dietary advice
Patients willing to provide signed & dated informed consent and
comply with study requirements.
Male and non pregnant female with age 18 years or more
Non-diabetic population should be matched in terms of age, sex and
centre

Exclusion Criteria Exclusion Criteria

Details Patient unwilling to comply with the study procedures
Pregnant & lactating women
History of cardiovascular event within the previous six months
Patients with specific co morbidities, which may impact the patients
diet, e.g malignant diseases, advanced dementia, Parkinson’s
disease and others
Suffering from chronic diseases including but not limited to chronic
renal failure, chronic liver disease that might interfere with
participation in the study as per physician discretion.
Patients on weight management plan e.g. low carbohydrate diet
which includes dietary modifications or dietary alterations

Method of Generating Not Applicable

Random Sequence
Method of Not Applicable
Concealment
Blinding/Masking Not Applicable
Primary Outcome Outcome Timepoints
Percentage of total energy intake as Time Frame: 1 day
carbohydrate by Indian diabetic population Time Frame: 1 day
Percentage of complex carbohydrate intake from
total carbohydrate by Indian diabetic population
Secondary Outcome Outcome Timepoints
Difference in the percentage of total energy Time Frame: 1 day
intake as carbohydrate by diabetic versus
non-diabetic population
Difference in the percentage of complex
carbohydrate content of diabetic versus
non-diabetic population

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Difference in the percentage of total energy

intake as proteins & fats by diabetics versus
non-diabetic population
Percentage of diabetics population who follows
diet plan
Percent of diabetic population with glycaemic
control
Target Sample Size Total Sample Size=800
Sample Size from India=800
Final Enrollment numbers achieved (Total)=
Final Enrollment numbers achieved (India)=
Phase of Trial Phase 4
Date of First 16/01/2012
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=3
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Completed
Trial (India)
Publication Details
Brief Summary − There are few smaller studies from Southern part of India, sparing that
we do not have larger studies which documents the dietary contents of diabetic
patients.

− There is a need to conduct dietary survey considering the diverse dietary

food habits in various parts of India.

− Interaction with KOL also suggested that merely only percentage of

diabetic population actually follows the dietary advice (Diet Plan)

− The purpose of the present cross-sectional study is to comprehend the

dietary pattern of diabetics and also find out how it compare with non-diabetic
population.

− This study results should also help us to conclusively describe the role
of α-glucosidase inhibitors like Glucobay in management protocol of diabetic
patients in India, which is presently not considered as very essential for
management of type-II diabetes mellitus.

- In addition, the study results should also assist to define the effective strategy
to address the role of α-glucosidase inhibitors in routine management of Indian
diabetic patients

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