Study to evaluate prevalence of Non-Alcoholic Steatohepatitis diagnosed through transient elastography & evaluate performance of various non-invasive liver fibrosis scores in Indian type 2 diabetes mellitus patients
Not Applicable
Completed
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2023/08/056193
- Lead Sponsor
- Dr Debmalya Sanyal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 351
Inclusion Criteria
patients with type 2 diabetes mellitus with or without other metabolic conditions ready to give consent for further evaluation of NASH through Transient elastography method
Exclusion Criteria
1. Participants with chronic viral hepatitis, significant alcohol consumption or other forms of liver disease
2. Participants who are on anti-diabetic medications like pioglitazone, GLP-1 RA for more than 3 months
3. Participants who are on medications like Saroglitazaar, Vitamin E, Pentoxifylline, Ursodeoxycholic acid (UDCA), Obeticholic Acid (OCA)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study will be to evaluate prevalence of Non Alcoholic Steatohepatitis (NASH) in T2DM through vibration controlled transient elastography (VCTE) & to evaluate performance / validation of non invasive liver fibrosis scores based on Area Under the Receiver Operating Characteristics (AUROC), Sensitivity, Specificity, Positive predictive value (PPV), & Negative predictive value (NPV)Timepoint: Baseline, as it is cross sectional study
- Secondary Outcome Measures
Name Time Method Association with metabolic conditions like obesity, hypertension, dyslipidemia & stage of liver fibrosis, will be evaluated.Timepoint: Baseline, as it is cross sectional study