| CTRI Number |
CTRI/2012/07/002763 [Registered on: 04/07/2012] Trial Registered Retrospectively |
| Last Modified On: |
05/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prevalence of chronic kidney disease among Indian subjects with type-2 diabetes |
|
Scientific Title of Study
|
A cross sectional observational study to determine the prevalence of chronic renal dysfunction among
type 2 diabetes mellitus patients
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Kalra |
| Designation |
Endocrinologist |
| Affiliation |
Bharti Hospital |
| Address |
Wazir Chand Colony,
Kunjpura Road, Karnal,
Haryana
Karnal
HARYANA
132001
India |
| Phone |
9896048555 |
| Fax |
|
| Email |
brideknl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kalra |
| Designation |
Endocrinologist |
| Affiliation |
Bharti Hospital |
| Address |
Wazir Chand Colony,
Kunjpura Road, Karnal,
Haryana
Karnal
HARYANA
132001
India |
| Phone |
9896048555 |
| Fax |
|
| Email |
brideknl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navneet Agarwal |
| Designation |
Director |
| Affiliation |
GR Medical College |
| Address |
Diabetes, Obesity & Thyroid Center,
19, Hospital Road, Lalitpur Colony, Gwalior (M.P.)
Gwalior
MADHYA PRADESH
474001
India |
| Phone |
919826511222 |
| Fax |
|
| Email |
navdotc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sitaram Shiksha evam Paryavaran Samaj Kalyan Samiti Reg |
|
|
Primary Sponsor
|
| Name |
Shri Sitaram Shiksha evam Paryavaran Samaj Kalyan Samiti Reg |
| Address |
2B/1, Yadav Colony, Near Ravishankar Medical Hostel, Gwalior, (M.P), India. |
| Type of Sponsor |
Other [Non-Government Organization] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Tech Observer India Pvt Ltd |
1391/34 A, Nagal raya New Delhi-110046 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Kalra |
Bharti Hospital |
Director room 1, Wazir Chand Colony, Kunjpura Road, Karnal, Haryana
Karnal
HARYANA
132001
India
Karnal
HARYANA |
9896048555
bridenknl@gmail.com |
| Dr Ganpathy Bantwal |
Department of Endocrinology |
St. John’s Medical College & Hospital, Sarjapura Road, Bangalore, Karnataka-560034
Bangalore
KARNATAKA |
91-9448067318
mallyaganapathi@rediffmail.com |
| Dr Rakesh Sahay |
Department of Endocrinology, |
2nd Floor, Golden Jubilee Block, Afzalgunj, Osmania Medical Hospital, Hyderabad, India
Hyderabad
ANDHRA PRADESH |
919849597507
sahayrk@gmail.com |
| Dr Tushar Bandgar |
Department of Endocrinology, KEM Hospital, |
KEM Hospital, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA |
919820025037
drtusharb@gmail.com |
| Dr Navneet Agrawal |
Diabetes, Obesity & Thyroid Center, |
19, Hospital Road, Lalitpur Colony, Gwalior (M.P.), 474001,
Gwalior
MADHYA PRADESH |
919826511222
navdotc@gmail.com |
| Dr Manash Barua |
Excel Care Hospitals |
Maya- Ville, Borthakur Mill Road, Ulubari,Guwahati, Assam- 781007
Bongaigaon
ASSAM |
9435018344
91-361-2464100
manashbaruahinin@yahoo.co.in |
| Dr Manisha Sahay |
Private clinic |
Consultant, 6-3-852A My Nest Greenland, Amarpreet Main Road, Hyderabad-16
Hyderabad
ANDHRA PRADESH |
919849597507
drmanishasahay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| CLINICOM, Independant Ethics Committe for Evaluation of Protocol for Clinical Reserach, Banglore (Dr Navneet Agrawal, Dr Manash P Baruah, Dr Sanjay Kalra, Dr Manisha Sahay) |
Approved |
| Ethics Committee for Research on Human Subjects (ECRHS), Seth GS Medical College & KEM Hospital, Parel Mumbai, Investigator: Dr Tushar Bandgar |
Submittted/Under Review |
| Ethics Committee, Osmania Medical College, Hyderabad, Investigator: Dr Rakesh Sahay |
Submittted/Under Review |
| Institutional Ethical Review Board, St JohnMedical College & Hospital, Banglore-560034, nvestigator: Dr Ganpathy Bantwal |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, Type 2 diabetes , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject with age ≥ 18 years
2. Subjects who give written informed consent to participate in the study
3. Subjects of either sex with confirmed diagnosis of type-2 diabetes
|
|
| ExclusionCriteria |
| Details |
1. Subjects with type-1 diabetes (Insulin dependent diabetes mellitus).
2. Subjects with any form of acute kidney injury based on investigator discretion.
3. Subjects who are pregnant or have positive urine pregnancy test (UPT)
4. Subjects with history of alcohol or drug abuse.
5. Female subjects who are actively menstruating
6. Subjects who have participated in any other study within past 3 months prior to entry in this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of type-2 diabetic subjects with chronic renal dysfunction |
Single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of subjects among different stages of chronic renal dysfunction
|
Single time point |
Ratio of chronic renal dysfunction subjects in various age group, gender and BMI(≤30kg/m2 and 30 kg/m2)
|
Single time point |
| Ratio of co-morbid conditions in different stages of chronic renal dysfunction |
Single time point |
|
|
Target Sample Size
|
Total Sample Size="1400"
Sample Size from India="1400"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/05/2012 |
| 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="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The current cross sectional observational study has been designed to determine the prevalence of chronic renal dysfunction among type-2 diabetics. In this study 1400 type -2 diabetic subjects will be enrolled at 7 centers across the country (India) to meet scientific objectives. The primary outcome of the study is percentage of type-2 diabetic subjects with chronic renal dysfunction and secondary objectives are: 1. Percentage of subjects among different stages of chronic renal dysfunction. 2. Ratio of chronic renal dysfunction subjects in various age group, gender and BMI(≤30kg/m2 and >30 kg/m2). 3. Ratio of co-morbid conditions in different stages of chronic renal dysfunction. The study will be terminated once the target enrollment is achieved. A maximum of 250 subjects will be enrolled at each participating sites over a period of 60 working days. First 10 subjects in a day who meet the eligibility criteria will be enrolled to participate into the study at each site. |