CompletedNot Applicable

Association of SGLT2 Inhibitors Therapy With Elastographic and Molecular Markers of Liver Injury in Type 2 Diabetes

Croatia67 participantsStarted 2024-03-22

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. Patients taking drugs that are extremely hepatotoxic, i.e., require additional monitoring of liver function during therapy (e.g., chemotherapeutic agents, biological therapy)
✕. 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.

What they're measuring

Change in liver fibrosis (kPa)

Timeframe: Baseline, after 6 months

Change in liver steatosis (dB/cm/MHz)

Timeframe: Baseline, after 6 months

Change in glucose levels (mmol/L)

Timeframe: Baseline, after 6 months

Change in HbA1c (%)

Timeframe: Baseline, after 6 months

Change in HbA1c (mmol/mol)

Timeframe: Baseline, after 6 months

Change in enzyme activity (U/L) of AST, ALT, GGT, ALP

Timeframe: Baseline, after 6 months

Change in Prothrombin Time ratio and change in activated Partial Thromboplastin Time ratio

Timeframe: Baseline, after 6 months

Change in Prothrombin Time-INR

Timeframe: Baseline, after 6 months

Trial details

NCT IDNCT07269197

SponsorJosip Juraj Strossmayer University of Osijek

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-10

View on ClinicalTrials.gov More Non-Alcoholic Fatty Liver Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. Patients taking drugs that are extremely hepatotoxic, i.e., require additional monitoring of liver function during therapy (e.g., chemotherapeutic agents, biological therapy)
✕. 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.

What they're measuring

Change in liver fibrosis (kPa)

Timeframe: Baseline, after 6 months

Change in liver steatosis (dB/cm/MHz)

Timeframe: Baseline, after 6 months

Change in glucose levels (mmol/L)

Timeframe: Baseline, after 6 months

Change in HbA1c (%)

Timeframe: Baseline, after 6 months

Change in HbA1c (mmol/mol)

Timeframe: Baseline, after 6 months

Change in enzyme activity (U/L) of AST, ALT, GGT, ALP

Timeframe: Baseline, after 6 months

Change in Prothrombin Time ratio and change in activated Partial Thromboplastin Time ratio

Timeframe: Baseline, after 6 months

Change in Prothrombin Time-INR

Timeframe: Baseline, after 6 months