Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Ranolazine: 500mg OD Oral for 12 months
Intervention2: Saroglitazar: 4mg OD Oral 12 months
Control Intervention1: Metformin
Atorvastatin: 500mg BD oral 12 months
10mg OD oral 12 month
Sponsors
Self
Eligibility
Inclusion criteria
Inclusion criteria: -Had ALT above upper limits of normal (19 U per L for women, 30 U per L for men). -Had ALD or NAFLD Index less than 0. -Had documented hepatic steatosis (Fatty Liver Index greater than equal to 60, NAFLD-FAT SCORE greater than minus 0.640, Hepatic steatosis index greater than equal to 36, NAFLD fibrosis score less than minus 1.455,Liver Accumulation Product greater than equal to 80). -HbA1C greater than equal to 7% -Willingness to comply with all protocol required evaluations; provision of written informed consent before any study specific tests or procedures are performed.
Exclusion criteria
Exclusion criteria: -Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilsons disease, hemochromatosis, etc.). -Average alcohol consumption greater than equal to 21 drinks per week formen, greater than equal to 14 drinks per week for women in the 6 months before enrollment. -The patients who already used medications known to cause hepatic steatosis for more than two weeks in the past year such as mipomersen, lomitapide, amiodarone, methotrexate, tamoxifen, corticosteroid, valproate, antiretroviral medicines. -Presence of alternative cause of fatty liver, including Total Parenteral Nutrition, Starvation, Lipodystrophy, -Abetalipoproteinemia, Acute fatty liver of pregnancy, HELLP syndrome, Reyeââ?¬•s syndrome. Clinical, imaging, or histological evidence of cirrhosis. -Use of drugs with a potential effect on NASH such as ursodeoxycholic acid, vitamin E, pioglitazone. -Pregnant or lactating female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Change from baseline serum AST, ALT, and GGT, HOMA-IR, HBA1c, BMI, Albumin, Total bilirubin, Triglycerides, Total cholesterol, HDL LDL, miRNA-122. -Variation in liver fat content as measured byFatty liver index and Liver accumulation product, NAFLD fibrosis score, Hepatic steatosis index, NAFLD Fat score. -Changes in liver fibrosis. Timepoint: 0, 90th day, 180th day, 270th day and 360th day | — |
Secondary
| Measure | Time frame |
|---|---|
| ADR monitoring during study periodTimepoint: 0, 90th day, 180th day, 270th day and 360th day | — |
Countries
India
Contacts
Public ContactDr K S Lakshmi
SRM Medical College Hospital and Research centre
Outcome results
None listed