NCT07269197Completed
Association of SGLT2 Inhibitors Therapy With Elastographic and Molecular Markers of Liver Injury in Type 2 Diabetes
The Association of Sodium-Glucose Cotransporter 2 Inhibitors Therapy With Elastographic and Molecular Markers of Liver Injury in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
Metabolic dysfunction-associated steatotic liver disease (MASLD), a condition where fat builds up in the liver, is common in patients with type 2 diabetes. Sodium-glucose cotransporter 2 (SGLT2) inhibitors may help improve liver health, but their effects on liver stiffness and fat are not yet well understood. This study aims to clarify these effects. Therefore, the aims of this study are: 1. Measurement of liver stiffness and liver steatosis using novel ultrasound-based methods before initiating SGLT2 inhibitor therapy and 6 months after starting therapy. 2. Assessment of blood biomarkers that may indicate liver injury, increased fat accumulation, and cellular dysfunction before initiating SGLT2 inhibitor therapy and 6 months after starting therapy. 3. Evaluation of the relationship between biomarkers and ultrasound findings before the introduction of SGLT2 inhibitors and 6 months after the start of therapy.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 67 (actual)
- First submitted
- 17 Nov 2025
- Start date
- 22 Mar 2024
- Primary completion date
- 10 Oct 2025
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- NCT number
- NCT07269197
What you commit to
- Study type: Observational
- Participants enrolled: 67
- From 22 Mar 2024 to the primary completion date, 10 Oct 2025
- 1 site 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.
Prior treatment
- Patients taking drugs that are extremely hepatotoxic, i.e., require additional monitoring of liver function during therapy (e.g., chemotherapeutic agents, biological therapy)
- Patients who are on insulin therapy
Other illness
- Patients taking drugs which cause drug-induced fatty liver disease (DIFLD): amiodarone, tamoxifen, methotrexate, 5-Fluorouracil, irinotecan, l-asparaginase, valproate, tetracycline, nucleoside reverse transcriptase inhibitors (NRTIs such as lamivudine, tenofovir, zidovudine etc.)
- Patients with liver cancer, hemochromatosis, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), hepatitis C virus (HCV), hepatitis B virus (HBV), liver cirrhosis or autoimmune hepatitis.
Other
- Patients who are alcohol addicted, i.e., consume more than two alcoholic beverages per day (for women) or more than three alcoholic beverages per day (for men)
- Mentally ill patients who are incapable of making their own independent decisions and have a legal custodian
- Pregnant women and nursing mothers
Who the study is looking for
- Signed informed consent, information for the participants and questionnaire
- Patients that are 18 years of age or older
- Diagnosis of type 2 diabetes mellitus
- Patients being treated with an SGLT2 inhibitor for the first time
- Patients who have been on stable antihyperglycemic therapy for 90 days (3 months) before enrollment in the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Health Center Osijek-Baranja County Coordinator of this site? Confirm its status | Osijek | Croatia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.