| CTRI Number |
CTRI/2020/06/026076 [Registered on: 23/06/2020] Trial Registered Prospectively |
| Last Modified On: |
17/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Observational study on newly diagnosed type 2 Diabetes patients in India |
|
Scientific Title of Study
|
A cross-sectional (baseline) & observational real world study on newly diagnosed patients with type 2 diabetes in India |
| Trial Acronym |
IDS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Unnikrishnan AG |
| Designation |
Chief Endocrinologist & CEO |
| Affiliation |
Chellaram Diabetes Institute |
| Address |
1 st Floor,Lalani Quantum, Pune-Bangalore Highway, Bavdhan Budruk
Pune
MAHARASHTRA
411021
India |
| Phone |
9689287337 |
| Fax |
|
| Email |
ceo@cdi.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Baishali Nath |
| Designation |
Assistant Manager- Medical Advisor |
| Affiliation |
Eris Lifesciences Ltd. |
| Address |
8th floor, commerce house IV, besides shell petrol pump, near Prahladnagar garden, 100 ft. road, satellite, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
8849494208 |
| Fax |
|
| Email |
baishali.nath@erislifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Baishali Nath |
| Designation |
Assistant Manager- Medical Advisor |
| Affiliation |
Eris Lifesciences Ltd. |
| Address |
8th floor, commerce house IV, besides shell petrol pump, near Prahladnagar garden, 100 ft. road, satellite, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
8849494208 |
| Fax |
|
| Email |
baishali.nath@erislifesciences.com |
|
|
Source of Monetary or Material Support
|
| Eris Lifesciences Ltd
8th floor, commerce house IV, besides shell petrol pump, near Prahladnagar garden, 100 ft. road, satellite, Ahmedabad 380015 |
|
|
Primary Sponsor
|
| Name |
Eris Lifesciences Ltd |
| Address |
8th floor, commerce house IV, besides shell petrol pump, near Prahladnagar garden, 100 ft. road, satellite, Ahmedabad 380015 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Unnikrishnan AG |
Chellaram Diabetes Institute |
1 st Floor, Lalani Quantum, Pune-
Bangalore Highway, Bavdhan Budruk
Pune
MAHARASHTRA |
9689287337
ceo@cdi.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chellaram Diabetes Institute Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients (Aged 18 Years or above) who were newly diagnosed with type 2 diabetes and referred to the clinic within 1 year of diagnosis.
2. Diagnosis of diabetes will be based on American Diabetes Association criteria. |
|
| ExclusionCriteria |
| Details |
1. Monogenic diabetes syndrome
2. Disease of the exocrine pancreas
3. Gestational Diabetes
4. Acute or severe chronic heart disease
5. Renal or psychiatric disease.
6. Initial evaluation in clinic after 1 year of diagnosis or unclear at time of diagnosis, type 1, type 1.5, or type 3 diabetes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To characterise/type/profile the newly diagnosed Indian patient with type 2 diabetes from the demographic details and laboratory investigations |
1 Year |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="13000"
Sample Size from India="13000"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Over the past few decades, various studies have been done to attempt to estimate the prevalence of diabetes in India. But till now no study has been done to characterize and classify newly detected type 2 diabetic population.
The purpose of the study to characterize/type/profile the newly diagnosed Indian patient with type 2 diabetes from the demographic details and baseline investigations. |