PDF of Trial CTRI Website URL

PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 20:06:07 GMT)

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 Trial Public Title of Study Prevalence of chronic kidney disease among Indian subjects with type-2 diabetes Scientific Title of A cross sectional observational study to determine the prevalence of chronic renal dysfunction Study among type 2 diabetes mellitus patients Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Sanjay Kalra Trial Coordinator (multi-center study) Designation Endocrinologist Affiliation Bharti Hospital Address Wazir Chand Colony, Kunjpura Road, Karnal, Haryana Karnal HARYANA 132001 India Phone 9896048555 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Sanjay Kalra Query) Designation Endocrinologist Affiliation Bharti Hospital Address Wazir Chand Colony, Kunjpura Road, Karnal, Haryana Karnal HARYANA 132001 India Phone 9896048555 Fax Email [email protected] Details Contact Details Contact Person (Public Query) 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 [email protected]

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Source of Monetary or Source of Monetary or Material Support Material Support > Shri Sitaram Shiksha evam Paryavaran Samaj Kalyan Samiti Reg Primary Sponsor Primary Sponsor Details 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 Name Address Sponsor Tech Observer India Pvt Ltd 1391/34 A, Nagal raya New Delhi-110046 Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Sanjay Kalra Bharti Hospital Director room 1, Wazir 9896048555 Chand Colony, Kunjpura Road, Karnal, [email protected] Haryana Karnal HARYANA 132001 India Karnal HARYANA Dr Ganpathy Bantwal Department of St. John’s Medical 91-9448067318 Endocrinology College & Hospital, Sarjapura Road, mallyaganapathi@rediff Bangalore, mail.com Karnataka-560034 Bangalore KARNATAKA Dr Rakesh Sahay Department of 2nd Floor, Golden 919849597507 Endocrinology, Jubilee Block, Afzalgunj, Osmania [email protected] Medical Hospital, Hyderabad, India Hyderabad ANDHRA PRADESH Dr Tushar Bandgar Department of KEM Hospital, Parel, 919820025037 Endocrinology, KEM Mumbai- 400012 Hospital, Mumbai [email protected] MAHARASHTRA Dr Navneet Agrawal Diabetes, Obesity & 19, Hospital Road, 919826511222 Thyroid Center, Lalitpur Colony, Gwalior (M.P.), 474001, [email protected] Gwalior MADHYA PRADESH Dr Manash Barua Excel Care Hospitals Maya- Ville, Borthakur 9435018344 Mill Road, 91-361-2464100 Ulubari,Guwahati, manashbaruahinin@ya Assam- 781007 hoo.co.in Bongaigaon ASSAM Dr Manisha Sahay Private clinic Consultant, 6-3-852A 919849597507 My Nest Greenland, Amarpreet Main Road, drmanishasahay@gmai Hyderabad-16 l.com Hyderabad

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ANDHRA PRADESH Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? CLINICOM, Approved 17/02/2012 Yes Independant Ethics Committe for Evaluation of Protocol for Clinical Reserach, Banglore (Dr Navneet Agrawal, Dr Manash P Baruah, Dr Sanjay Kalra, Dr Manisha Sahay) Ethics Committee for Submittted/Under No Date Specified No Research on Human Review Subjects (ECRHS), Seth GS Medical College & KEM Hospital, Parel Mumbai, Investigator: Dr Tushar Bandgar Ethics Committee, Submittted/Under No Date Specified No Osmania Medical Review College, Hyderabad, Investigator: Dr Rakesh Sahay Institutional Ethical Submittted/Under No Date Specified No Review Board, St Review JohnMedical College & Hospital, Banglore-560034, nvestigator: Dr Ganpathy Bantwal Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Chronic kidney disease, unspecified Patients Type 2 diabetes Intervention / Type Name Details Comparator Agent Inclusion Criteria 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
Exclusion Criteria Exclusion Criteria 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

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6. Subjects who have participated in any other study within past 3 months prior to entry in this study.

Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Percentage of type-2 diabetic subjects with Single time point chronic renal dysfunction Secondary Outcome Outcome Timepoints Percentage of subjects among different stages of Single time point chronic renal dysfunction

Ratio of chronic renal dysfunction subjects in Single time point various age group, gender and BMI(?30kg/m2 and 30 kg/m2)

Ratio of co-morbid conditions in different stages Single time point of chronic renal dysfunction 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 14/05/2012 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=4 Days=0 Recruitment Status of Completed Trial (Global) Recruitment Status of Completed Trial (India) Publication Details None Yet 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.

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