Improvement in liver disease activity in patients with non-alcoholic fatty liver disease (NAFLD) with lifestyle behavioral modification in form of hypocaloric diet consumed in pattern of intermittent fasting compared with no fasting.
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
- Registration Number
- CTRI/2022/11/047684
- Lead Sponsor
- Dr Deepankshi Aggarwal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) NAFLD patients will be defined by the evidence of hepatic steatosis, either by ultrasound or Fibroscan with no significant alcohol consumption (less than 20g/day) and after excluding alternate causes of steatosis and/or raised hepatic transaminases (including but not limited to drug intake, chronic Hepatitis B and C, autoimmune hepatitis, hemochromatosis, Wilsonâ??s disease, celiac disease).
2) Overweight and Class I Obese patients as per Asia-Pacific criteria (BMI greater than or equal to 23 ,and less than 30 Kg/m2).
3) Consent to participate in study.
1) Patients who are not willing to give consent for the study.
2) Patients having Type 2 Diabetes mellitus.
3) Patients who have evidence of cirrhosis liver on ultrasound or Fibroscan (LSM greater than or equal to 12.5 kPa).
3) Patients with history of hepatic decompensation.
4) Patients with class II obesity as per Asia-Pacific criteria (BMI greater than or equal to 30 Kg/m2).
5) Patients taking weight loss drugs.
6) Patients taking pharmacotherapy for NASH (e.g. Pioglitazone, Vit E and Saroglitazar).
7) Patients with post bariatric surgery status.
8) Pregnant / lactating females. Those non pregnant female patients recruited in the study who will conceive during the study period will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in hepatic steatosis grading as assessed by Controlled Attenuation Parameter (CAP) on FibroScan. <br/ ><br> <br/ ><br>Timepoint: 6 months <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Achievement of 5-10% weight reduction from baseline.Timepoint: 6 months;Change in body weight and BMITimepoint: 6 months;Change in HDL and TriglyceridesTimepoint: 6 months;Change in insulin resistance as assessed by HOMA-IRTimepoint: 6 months;Improvement in central obesity in terms of waist circumferenceTimepoint: 6 months;Improvement in hypertensive controlTimepoint: 6 months;Reduction in hepatic fibrosis as assessed by APRI, FIB-4, NFS and LSM on FibroscanTimepoint: 6 months;Reduction in liver inflammation as measured by ALT levels and FAST scoreTimepoint: 6 months