Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Intermittent fasting: Hypocaloric diet (30% reduction) to be consumed within 8 hours of the day with 16 hours of continuous fasting every day , Physical exercise 150-200 minutes/week
Du
Sponsors
Dr Deepankshi Aggarwal
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in hepatic steatosis grading as assessed by Controlled Attenuation Parameter (CAP) on FibroScan. Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Arka De
Postgraduate Institute of Medical Education and Research
Outcome results
None listed