Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: o NAFLD patients will be defined by the evidence of hepatic steatosis by Fibroscan with controlled attenuation parameter (CAP) >248 dB/m in the absence of significant alcohol intake ( >20 g/day irrespective of gender) or other concomitant etiologies of liver disease o All patients must be on stable doses of medical therapy for 6 weeks before the study start date. o Be willing and able to participate in the full program o Be willing and able to functionally participate in all activities set as part of the intervention o Be able to complete all day-to-day activities and instrumental activities of daily living independently, completely without assistance from others o Age eighteen years to sixty years
Exclusion criteria
Exclusion criteria: o Patients with cirrhosis (LSM >13.6 kPa) o Any patient on drugs causing change in steatosis including SGLT2 inhibitors,GLP1 agonists, Vitamin E, Saroglitazar, and thiazolidinediones o Pregnant, lactating women o Patients who will not be able to carry out yoga and exercise protocol safely, recent fall or > 3 falls in a year, recent hospitalization in 1 month, and those who fail to give consent will be excluded o Significant alcoholic consumption ( >20 g/day irrespective of gender) o Competing etiology for hepatic steatosis like Hep C, Medications, parenteral nutrition, Wilsonâ??s disease and severe malnutrition o Coexisting causes for chronic liver disease (CLD) including hemochromatosis, autoimmune liver disease, chronic viral hepatitis, Wilsons Disease and drug induced liver injury o The patients with severe cardio-pulmonary disease, coronary artery disease, cardiomyopathy, severe musculoskeletal disease, neuropsychiatric disease, and history of cardiovascular accident. o Any patient not meeting any part of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CAP at 6 monthsTimepoint: baseline and after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| b. Change in body weight at 6 months c. Change in waist circumference at 6-months d. Change in blood pressure at 6 months e. Change in Liver functions, Lipid profile, HbA1C at 6 months f. Change in insulin resistance (as assessed by HOMA-IR) at 6 months g. Change in hepatic inflammation (as assessed by ALT and FAST scores) and fibrosis (as assessed by APRI, FIB-4, NFS and LSM) by at 6 months h. Change in serum cytokines/adipocytokines (CRP, IL-6, TNF alpha, leptin, adiponectin) i. Change in quality of life at 6 months Timepoint: baseline and after 6 months | — |
Countries
India
Contacts
PGIMER, Chandigarh