Effect of Metformin in combination with Empagliflozin and Linagliptin on laboratory markers in type 2 diabetic patients with metabolic fatty liver

Effect of Metformin in combination with Empagliflozin and Linagliptin separately and simultaneously on lipid peroxidation markers and ferroptosis-related miRNAs in type 2 diabetic patients with metabolic fatty liver: A randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N603

Enrollment

Registered

2026-04-12

Start date

2026-04-30

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty liver. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group 1: Metformin tablets 1000 mg (Manufactured by Abou Reihan Co.) once daily plus empagliflozin tablets 12.5 mg (Manufactured by Abidi Co.) once daily for 24 weeks. Int

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age 18 to 75 years, Type 2 diabetes for at least 6 months, Fatty liver with metabolic dysfunction, Hemoglobin A1c between 6.8 and 9.0 percent, Body mass index between 25 and 40 kg/m2,

Exclusion criteria

Exclusion criteria: Pregnancy or lactation, Heart disease, Liver failure, Alcohol or substance abuse

Design outcomes

Primary

Measure	Time frame
Glutathione peroxidase level. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.;Malondialdehyde level. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.;Reduced glutathione level. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.;Expression level of microRNA related to the ferroptosis process in serum. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.;Ferritin level. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.;Transferrin level. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.;Serum iron level. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.	—

Measure

Time frame

Glutathione peroxidase level. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.;Malondialdehyde level. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.;Reduced glutathione level. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.;Expression level of microRNA related to the ferroptosis process in serum. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.;Ferritin level. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.;Transferrin level. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.;Serum iron level. Timepoint: Before the intervention and 24 weeks later. Method of measurement: Through blood sampling and ELISA test.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMelika Shalileh

Hamedan University of Medical Sciences

mlk.shalileh@gmail.com+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026