Dapagliflozin in Nonalcoholic Fatty Liver Disease (NAFLD) and Type 2 Diabetes Mellitus Patients (T2DM).

Condition(s) studied

Investigational drug(s) / intervention(s)

Dapagliflozin (DAPA): dapagliflozin 10mg tab once daily for NAFLD patient

Placebo: placebo

Negative control: Baseline sample serum without either drug or placebo

Study summary

Nonalcoholic fatty liver disease (NAFLD) encompasses conditions such as nonalcoholic steatohepatitis (NASH), which involves liver inflammation and fibrosis resulting from steatosis, potentially leading to cirrhosis and hepatocellular carcinoma. NAFLD is intricately linked to metabolic syndrome, with insulin resistance and hyperinsulinemia as key underlying factors. particularly among individuals with type2 diabetes. NAFLD is an independent risk factor for cardiovascular events, negatively impacting life expectancy in diabetic patients, and it exacerbates insulin resistance and glucose intolerance.

Early intervention in diabetes complicated by NAFLD is vital due to associations with hepatocarcinogenesis and macrovascular complications. Sodium-glucose cotransporter2 (SGLT2) inhibitors, which promote glucose excretion and reduce insulin dependence, have shown significant hypoglycemic effects, weight reduction, and potential benefits on liver function. Dapagliflozin, a specific SGLT2 inhibitor, has been proven effective in lowering hyperglycemia in type 2 diabetes and mitigating NAFLD-related complications in animal models. This study aimed to evaluate the impact of dapagliflozin on liver function in NAFLD patients with type2 diabetes. Eligible participants received dapagliflozin for 24weeks, with assessments including body composition, serum biochemistry, and molecular parameters to determine therapeutic outcomes.

Eligibility

Primary outcome measure(s)

• Fibroscan — 6 months
  Decrease in liver stiffness by measure CAP
• soluble vascular cell adhesion molecule-1 (Svcam-1) — 6 months
  VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits.
• adiponectin — 6 months
  adiponectin by enzyme-linked immunosorbent assay (ELISA).
• leptin — 6 months
  leptin by enzyme-linked immunosorbent assay (ELISA).

Trial sites (2)

Other trials for the same condition