| CTRI Number |
CTRI/2019/06/019672 [Registered on: 14/06/2019] Trial Registered Prospectively |
| Last Modified On: |
12/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Association of liver disease with obesity in people having diabetics. |
|
Scientific Title of Study
|
Prevalance of non-alcoholic fatty liver disease in obese and non-obese diabetics-a comparative study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashank Bhardwaj |
| Designation |
Resident |
| Affiliation |
Batra Hospital and Medical Research Centre |
| Address |
Department of medicine, OPD Block, Ground Floor, New Building
Batra Hospital and Medical Research Centre, Mehrauli Badarpur road, New Delhi
New Delhi
DELHI
110028
India |
| Phone |
8920744429 |
| Fax |
|
| Email |
shashank.bhrdwaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Juhi Dhar |
| Designation |
Consultant |
| Affiliation |
Batra Hospital and Medical Research Centre |
| Address |
Department of medicine, OPD Block, Ground floor, New building
Batra Hospital and medical research centre, mehrauli badarpur road, New Delhi
New Delhi
DELHI
110028
India |
| Phone |
8920744429 |
| Fax |
|
| Email |
juhidhar24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank Bhardwaj |
| Designation |
Resident |
| Affiliation |
Batra Hospital and Medical Research Centre |
| Address |
Department of medicine, OPD Block, Ground floor, New building
Batra Hospital and Medical Research Centre, Mehrauli Badarpur Road, New Delhi
New Delhi
DELHI
110028
India |
| Phone |
8920744429 |
| Fax |
|
| Email |
shashank.bhrdwaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Batra Hospital and Medical Research Centre, Mehrauli Badarur Road, New Delhi. |
|
|
Primary Sponsor
|
| Name |
Batra Hospital and Medical Research Centre |
| Address |
Mehrauli Badarpur Road, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shashank Bhardwaj |
Batra Hospital and Medical Research Centre |
Department of medicine, Medicine OPD, Ground floor, New building
New Delhi
DELHI |
8920744429
shashank.bhrdwaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BATRA HOSPITAL AND MEDICAL RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K760||Fatty (change of) liver, not elsewhere classified, (2) ICD-10 Condition: E669||Obesity, unspecified, (3) 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 |
Type 2 Diabetes |
|
| ExclusionCriteria |
| Details |
1) History of alcohol intake (more than 20 gms in per day in males and more then 10 gms per day in females).
2) Chronic liver disease like Hepatitis C and Hepatitis B, Autoimmune hepatitis.
3) History of taking drugs known to cause fatty liver disease E.g. Amidarone, tamoxifen, Glucocorticoids, Esterogens.
4) Recent and past illness known to cause NAFLD like protein energy malnutrition, starvation, patient on Total parenternal nutrition , Gastrointestinal surgery for obesity, inflammatory bowel disease, Wilson disease .
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of NAFLD in patients of type2 diabetes mellitus. |
1 Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between obesity and NAFLD in diabetics |
1 Day |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
01/07/2019 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In India, there is lack of data regarding prevalance of NAFLD in diabetics and its further link to obesity. Diabetes and obesity have been proven to be independent risk factors for NAFLD, but both are commonly found together. The interplay between diabetes, NAFLD and obesity needs to be studied in detail. Hence, this study is planned to study the prevalance of NAFLD in obese and non-obese diabetics. |