NCT07020377Active, not recruitingPhase 1/2
Dapagliflozin in Nonalcoholic Fatty Liver Disease (NAFLD) and Type 2 Diabetes Mellitus Patients (T2DM).
The Hepato-protective Effect of Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)
Source: ClinicalTrials.gov · Last updated 13 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 7 Nov 2024
- Start date
- 15 Jan 2024
- Primary completion date
- 20 Dec 2025
- Lead sponsor
- Amira Bisher,PhD
- NCT number
- NCT07020377
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From 15 Jan 2024 to the primary completion date, 20 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with a history of alcohol, smoking, uncontrolled diabetes.
- Chronic liver and decompensated liver disease in hepatitis B and C.
Lab values
- patients whose abdominal ultrasounds findings were extremely abnormal (mass, fibrosis, ascites, and cirrhosis) and amino transaminase levels were severely high (ALT and AST greater than 15 times the upper limit of normal according to Johns Hopkins Diabetes Guide) suggest severe liver cell injury was also worked for acute viral hepatitis.
Other
- Pregnancy.
- Lactation.
Who the study is looking for
- Patients with Type 2 diabetes mellitus patients.
- Patients were having fatty liver changes by fibro scan and with mild to moderate elevation of serum liver enzymes or without.
- patients taking insulin or anti-diabetic medications.
- Patients have Renal dysfunction.
- Patients have Cardiac problem
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alexandria university main hospital Coordinator of this site? Confirm its status | Alexandria | Egypt | Unknown status |
| Egyptian liver hospital Coordinator of this site? Confirm its status | Al Mansurah | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.