Non-alcoholic fatty liver disease Diabetes patient NAFLD DM type II Insulin resistance SGLT2 inhibitor Fatty liver
Conditions
Interventions
Dapagliflozin 10 mg Tablets,
12 weeks,Matching placebo to Dapagliflozin 10 mg Tablets,
Experimental Drug,Placebo Comparator Drug
Sponsors
The Faculty of Medicine endownment Fund
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18 -75 years 2.Patient with T2DM who are on standard medications (metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonist, alpha-glucosidase inhibitor, thiazolidinedione, in any combination) for at least 24 weeks, with stable diabetic parameters (HbA1c, FBS) and dosage 3.HbA1c more than 7.0% but less than 10.0% 4.No history of alcohol consumption of more than 10 g/d in female and 20 g/d in male in past 12 months 5.No other conditions that may lead to fatty liver by history, physical examination, and appropriate testing 6.Diagnosed NAFLD by non-contrast CT scan in past 12 months 7.The subject has provided written informed consent prior to admission the study
Exclusion criteria
Exclusion criteria: 1.Presence of severe acute or chronic diseases (liver, heart, renal failure), infectious or autoimmune liver diseases (positive for hepatitis B surface antigens, anti-hepatitis C virus, anti-nuclear or anti-mitochondrial antibodies) 2.Known history or clinical evidence of liver cirrhosis 3.Known allergy to SGLT2 inhibitors medication 4.Patient with T2DM on insulin therapy 5.Taken any weight loss medications within 3 months prior to admission to the study 6.Participants treated with vitamin E in the past immediate 6 months 7.eGFR by CKD-epi method < 60 ml/min/1.73m2 8.Pregnancy and breastfeeding 9.Lake of ability or willingness to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Dapagliflozin on improvement of NAFLD 12 weeks Liver attenuation index by Non-contrast CT scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of NASH and metabolic parameters 12 weeks measured all fat area, visceral fat area, subcutaneous fat area and girth by semiautomatic software ,Improvement of body composition 12 weeks Body weight, Body mass index, waist circumference, visceral fat to subcutaneous fat ratio in non-contrast CT scans,Improvement od metabolic parameter 12 weeks HOMA-IR, Leptin, adiponectin and TNF-alpha | — |
Countries
Thailand
Contacts
Public ContactSUSRICHIT PHRUEKSOTSAI
Faculty of Medicine, Chiang Mai University
Outcome results
None listed