FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066241 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Screening of Liver Fibrosis Using APRI and FIB4 score in Individial With Diabetes Type 2 in Medicine Department of Sir Takhtsinhji Hospital Bhavnagar 
Scientific Title of Study   Assessment Of Association Between APRI Score And FIB4 Score With Liver Fibrosis Among Diabetes Type 2 Patients In Medicine Department Of Sir Takhtsinhji Hospital Bhavnagar 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priteshkumar Patel 
Designation  Post Graduate 2nd year resident 
Affiliation  Sir Takhatsinhji General Hospital Bhavnagar 
Address  Opd no.62, Medicine department, Sir Takhtasinhji Hospital Campus, Bhavnagar-364001 Sir T Hospital, Bhavnagar, Gujarat Bhavnagar GUJARAT

Bhavnagar
GUJARAT
364001
India 
Phone  8980488088  
Fax    
Email  pritesh808@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj J Akholkar 
Designation  Associate Professor 
Affiliation  Sir Takhatsinhji General Hospital Bhavnagar 
Address  Department of Medicine, Medical College and Sir T hospital, Bhavnagar, Gujarat, India Sir T Hospital, Bhavnagar, Gujarat Bhavnagar GUJARAT

Bhavnagar
GUJARAT
364001
India 
Phone  9825312175  
Fax    
Email  drpankaj_md@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Priteshkumar Patel 
Designation  Post Graduate 2nd year resident 
Affiliation  Sir Takhatsinhji General Hospital Bhavnagar 
Address  Opd no.62, Medicine department, Sir Takhtasinhji Hospital Campus, Bhavnagar-364001 Sir T Hospital, Bhavnagar, Gujarat Bhavnagar GUJARAT

Bhavnagar
GUJARAT
364001
India 
Phone  8980488088  
Fax    
Email  pritesh808@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College & Sir Takhatsinhji General Hospital Bhavnagar-364001 (Gujarat), India. 
 
Primary Sponsor  
Name  Priteshkumar Patel 
Address  OPD no.62, Department of Medicine Sir Takhtsinhji General Hospital, Bhavnagar- 364001 (Gujarat) 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Priteshkumar Patel  Sir Takhtsinhji General Hospital, Bhavnagar  Diabetic OPD and Medicine Department OPD and Ward
Bhavnagar
GUJARAT 		 8980488088

pritesh808@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Government Medical College,Bhavnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All individuals with DM type 2 above the age of 18 years under Medicine Department, Sir T hospital for our study.
 
 
ExclusionCriteria 
Details  1.Secondary causes of fatty liver(Infective, Alcoholic, Genetic)
2.Hypothyroidism,CCF
3.Pregnant women
4.Individuals using/having used hepatotoxins (acetaminophen, methotrexate, nitrofurantoin, rifampicin & heavy metals).
5.Thrombocytopenia because of other causes 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the association between APRI score and FIB4 score with Liver Fibrosis among Diabetes Type 2 patients in medicine department of Sir Takhtsinhji hospital Bhavnagar  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess age and gender wise distribution of liver fibrosis using same scoring system in DM type 2 patients.
2.To establish the relation between duration of type 2 DM and liver fibrosis using different scoring system.
3.To establish relation between obesity with type 2 DM and Liver fibrosis using different scoring system
4.To compare the APRI score and FIB4 score for screening of liver fibrosis among T2DM patients in medicine department of Sir Takhtasinhji Hospital, Bhavnagar.
5.To establish relation between USG Abdomen finding with Liver fibrosis using different scoring system
in T2DM patients  		 6 months 
 
Target Sample Size   Total Sample Size="348"
Sample Size from India="348" 
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)   01/05/2024 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is a Prospective Observational Study used to assess the association between APRI score and FIB4 score with Liver Fibrosis among Diabetes Type 2 patients in medicine department of Sir Takhtsinhji hospital Bhavnagar

•Diabetes Mellitus Type 2 is a chronic, metabolic disease characterized by elevated levels of blood glucose. This disease affect all body systems, including the liver.
•
•Hyperglycemia, mainly caused by insulin resistance, affects the metabolism of lipids, carbohydrates and proteins and can lead to non-alcoholic fatty liver disease(NAFLD), which can further progress to non-alcoholic steatohepatitis(NASH), cirrhosis and, finally, hepatocellular carcinomas(rarely).

•Routine screening for Liver fibrosis is not currently recommended for patients with diabetes or otherwise increased risk in the absence of elevated liver transaminases or other evidence for liver disease.
•
•This reflects a lack of adequate, evidence-based methods for Liver fibrosis screening and also uncertainties about how to effectively treat Liver Fibrosis once diagnosed. 
•
•it will be important to continuously re-evaluate the cost-effectiveness of screening. Since the rate of progression from simple steatosis (NAFL) to steatosis with associated inflammation and fibrosis (NASH) appears to be quite low.
•
•Patients at low risk for advanced fibrosis are followed-up every 2 years by repeating liver enzymes and fibrosis scores,
•whereas those at intermediate or high risk need to be referred to specialists to exclude other chronic liver diseases, to better assess disease severity and possibly to initiate specific therapy.
 
Close