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

Sponsor
Amira Bisher,PhD
Study ID
NCT07020377
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Diabetes Mellitus
  • Non Alcholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin (DAPA) — DRUG
    dapagliflozin 10mg tab once daily for NAFLD patient
  • Placebo — DRUG
    placebo
  • Negative control — OTHER
    Baseline sample serum without either drug or placebo

Study Details

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.

Key Dates

Start date
Jan 15, 2024
Status verified
Nov 2024
Primary completion
Dec 20, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Positive control
  • Active Comparator: Dapagliflozin 10mg
    The group which takes the medication (dapagliflozin)
  • Other: Negative control
    healthy participants without any medication

Primary Outcome Measure

Fibroscan [ Time Frame: 6 months ]

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