Clinical profile of non alcoholic fatty liver disease and significance of hsCRP
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Predict severity of Non
Study Overview
Brief Summary
Justification for study: Non alcoholic fatty liver disease is the most common cause of chronic liver disease worldwide. The global prevalence of Non alcoholic fatty liver disease is estimated to be as high as one billion. Liver biopsy being the gold standard, is too invasive, there’s a chance of sampling error and costly. There is a pressing need for more viable non invasive markers of severity. Timely intervention can revert the disease progression and play a significant role in bringing down the morbidity associated with the disease
Detailed description of procedure / processes: All patients admitted to Kasturba Hospital in the study period who are diagnosed as grade 2 and grade 3 fatty infiltration on USG abdomen, who meet the inclusion, exclusion criteria will be recruited for the study. Written and informant consent will be taken from the participants before initiating the study. Anthropometric data, investigative data including hsC-reactive protein levels and elastoscan reports are obtained from the proforma. Non alcoholic fatty liver fibrosis score and FIB4 score will be calculated using parameters obtained from the proforma. The above data will be compared and analyzed. Outcome measures include significance of hsCRP in NAFLD in predicting severity of NAFLD, study clinical profile of NAFLD, accuracy of non-invasive scoring systems of NAFLD
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All patients admitted to Kasturba Hospital during the study period who’s USG shows grade 2 or 3 fatty infiltration of the liver.
Exclusion Criteria
- •Patients with history of significant/hazardous levels of alcohol consumption (ie.
- •more than one drink per day in women and two drinks per day in men based on epidemiologic evidence that the prevalence of serum aminotransferase elevations increases when alcohol consumption habitually exceeds these levels.
- •In those studies, one drink was defined as having 10 g of ethanol and, thus, is equivalent to one can of beer, 4 oz of wine, or 1.5 oz (one shot) of distilled spirits.), Patients with Connective Tissue disorders, Patients with chronic kidney disease, Patients with acute or chronic Hepatitis B or C infections, Patients with recent history of trauma, Patients with malignancies.
Outcomes
Primary Outcomes
Predict severity of Non
Time Frame: At baseline
Alcoholic Fatty liver by using hsCRP
Time Frame: At baseline
Secondary Outcomes
- Not applicable(Not applicable)
Investigators
Sanju George
Kasturba Medical College, Manipal academy of higher education