Investigating the effect of empagliflozin on thyroid function in patients with non-alcoholic fatty liver disease (NAFLD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250713066469N1

Enrollment

Registered

2025-07-30

Start date

2026-03-21

Completion date

Unknown

Last updated

2025-08-19

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

Conditions

Non-alcoholic fatty liver.

Interventions

Intervention 1: They received the drug empagliflozin. Intervention 2: Control group: Diet and exercise.

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age group 30 to 70 years Non-alcoholic fatty liver disease (confirmed by ultrasound)

Exclusion criteria

Exclusion criteria: Alcohol consumption of more than 20 grams per day History of hepatitis B or C virus infection, autoimmune hepatitis, other liver diseases Taking any hepatotoxic or thyroid medications pregnancy / breastfeeding History of cancer or treatment for thyroid cancer within the past 2 years BMI more than 40

Design outcomes

Primary

Measure	Time frame
TSH. Timepoint: o-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters of thyroid-stimulating hormone, thyroxine and triiodothyronine. All values will be measured by standard methods.;T4. Timepoint: o-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters of thyroid-stimulating hormone; thyroxine and triiodothyronine. All values will be measured by standard methods.;T3. Timepoint: o-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters of thyroid-stimulating hormone; thyroxine and triiodothyronine. All values will be measured by standard methods.	—

Measure

Time frame

TSH. Timepoint: o-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters of thyroid-stimulating hormone, thyroxine and triiodothyronine. All values will be measured by standard methods.;T4. Timepoint: o-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters of thyroid-stimulating hormone; thyroxine and triiodothyronine. All values will be measured by standard methods.;T3. Timepoint: o-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters of thyroid-stimulating hormone; thyroxine and triiodothyronine. All values will be measured by standard methods.

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Secondary

Measure	Time frame
Alanine aminotransferase. Timepoint: 0-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), high density lipoprotein (HDL).;Aspartate aminotransferase. Timepoint: 0-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), high density lipoprotein (HDL).;Alkaline phosphatase. Timepoint: 0-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), high density lipoprotein (HDL).;Fatty liver grade. Timepoint: 0-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), high density lipoprotein (HDL).	—

Measure

Time frame

Alanine aminotransferase. Timepoint: 0-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), high density lipoprotein (HDL).;Aspartate aminotransferase. Timepoint: 0-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), high density lipoprotein (HDL).;Alkaline phosphatase. Timepoint: 0-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), high density lipoprotein (HDL).;Fatty liver grade. Timepoint: 0-3-6 months. Method of measurement: Fasting venous whole blood samples will be obtained to measure the biochemical parameters alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), high density lipoprotein (HDL).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Saeedinasab

Yasouj University of Medical Sciences

neda.sdi77@gmail.com+98 917 810 8067

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026