Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Not applicable: Not applicable as this is observational study
Control Intervention1: Not applicable: Not applicable as this is observational study
Sponsors
Dr Debmalya Sanyal
Eligibility
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Association with metabolic conditions like obesity, hypertension, dyslipidemia & stage of liver fibrosis, will be evaluated.Timepoint: Baseline, as it is cross sectional study | — |
Countries
India
Contacts
Public ContactDr Kunal Jhaveri
Zydus Lifesciences Limted
Outcome results
None listed