| 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 Study
|
Epidemiological study to evaluate the dietary composition of Indian type-2 diabetic patients compared to non-diabetic population |
| Trial Acronym |
STARCH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NN1120IN |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DR SHASHANK R JOSHI |
| 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 |
shashank.sr@gmail.com |
|
Details of Contact Person
Scientific 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
Thane
MAHARASHTRA
400 607
India |
| Phone |
912225311431 |
| Fax |
912225455007 |
| Email |
rahul.rathod@bayerzyduspharma.com |
|
Details of Contact 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 |
| Fax |
912225455007 |
| Email |
rahul.rathod@bayerzyduspharma.com |
|
|
Source of Monetary or Material Support
|
| BayerZydus Pharma Pvt ltd
Kolshet road,Thane - 400 607
Maharashtra |
|
|
Primary Sponsor
|
| Name |
Bayer Pharmaceuticals |
| Address |
Bayer Pharma Private Limited, Kolshet Road, Thane, Maharashtra, India. Pin – 400607 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mala Dharmalingam |
Bangalore Endocrinology & Diabetes Research center |
Dept of Endcrinology,35, 5th Cross, Malleshwaram Circle,Near Biz Bazaar, Next to Indian Bank, Bengaluru 560 003
Bangalore
KARNATAKA |
9845208163
endocrinology23@rediffmail.com |
| Dr Sarita Bajaj |
Dr. Sarita Bajaj |
3/6,Panna lal road, Allahabad - 211 002,UP,India
Allahabad
UTTAR PRADESH |
9415239392
drsarita.bajaj@gmail.com |
| Dr Subodh Banzal |
Dr. Subodh Banzal |
"107,Trade House, Opp Dhakkanwala Kua,
South Tukoganj,
INDORE."
Indore
MADHYA PRADESH |
9893693006
subodhbanzal@gmail.com |
| Dr Swapan Sarkar |
Dr. Swapan Sarkar |
"Ganraj Chowmuhani, Banamalipur, P.O. Agartala , Tripura west ,PIN: 799007
North Tripura
TRIPURA |
9436120269
swapanagt1958@yahoo.com |
| DrR K Sahay |
Dr.R K Sahay |
MY NEST"6-3-852/A,AMERPREET ,HYDERABAD - 500016
Hyderabad
ANDHRA PRADESH |
9849597507
sahayrk@gmail.com |
| DrShachin Gupta |
Dr.Shachin Gupta |
"8/2,Sanjay complex,
Near Mata Mandir,
South T T Nagar
Bhopal-462 003"
Bhopal
MADHYA PRADESH |
9425010103
shachinseema@yahoo.com |
| Dr Parag Shah |
Gujarat Endocrine Centre |
201,2nd floor, Silver Brook-B,
Opp. Doctor House,
Nr. Parimal Crossing,
Ellisbridge,
Ahmedabad-380006.
Ahmadabad
GUJARAT |
9824042688
paragendocrine@yahoo.com |
| DrSatinath Mukhopadhyay |
Institute of Post Graduate Medical Education & Research |
244,AJC Bose Road,Ronald Ross Building,4th Floor, Room No 9,Kolkata-700020
Kolkata
WEST BENGAL |
9830027985
satinath59@hotmail.com |
| Dr Shashank Joshi |
Joshi Clinic |
Block 12, Golden Palace, Behind Union Bank, Turner Road, Bandra (W)- Mumbai-400050
Mumbai
MAHARASHTRA |
9820186302
shashank.sr@gmail.com |
| Dr Anil Bansali |
Post Graduate Institute of Medical Education & Research |
Department of Endocrinology Chandiragh-160012
Chandigarh
CHANDIGARH |
9316977995
anilbhansali_endocrine@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Bangalore Endocrinology & Diabetes Research center Ethics Committee on Human Research ,Bangalore |
Approved |
| CLINICOM Bangalore - Dr Banzal |
Approved |
| CLINICOM Bangalore - Dr Gupta |
Approved |
| CLINICOM Bangalore - DR Sahay |
Approved |
| CLINICOM BANGALORE - Dr Sarkar |
Approved |
| CLINICOM Bangalore - Dr Shah |
Approved |
| CLINICOM Bangalore - Dr Shashank Joshi |
Approved |
| CLINICOM Bangalore -Dr Bajaj |
Approved |
| Institute Ethics Committee Post Graduate Institiute of Medical Education & Research,Chandigarh |
Approved |
| IPGME&R Research Oversight Committee,IPGMER Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetic population and non diabetic populaion, |
|
|
Intervention / Comparator Agent
|
|
|
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
|
|
| ExclusionCriteria |
| 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 Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of total energy intake as carbohydrate by Indian diabetic population
Percentage of complex carbohydrate intake from total carbohydrate by Indian diabetic population |
Time Frame: 1 day
Time Frame: 1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difference in the percentage of total energy intake as carbohydrate by diabetic versus non-diabetic population
Difference in the percentage of complex carbohydrate content of diabetic versus non-diabetic population
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 |
Time Frame: 1 day |
|
|
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 Enrollment (India)
|
16/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 a-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 a-glucosidase inhibitors in routine management of
Indian diabetic patients |