Evidence map›Paper›PMID 40011855›Full record

Trial reportBMC endocrine disorders2025

The effect of empagliflozin on non-alcoholic fatty liver disease-related parameters in patients with type 2 diabetes mellitus: a randomized controlled trial.

Fatemeh Shojaei, Azam Erfanifar, Saeid Kalbasi, Shahriar Nikpour, Latif Gachkar

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC endocrine disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Fatemeh ShojaeiInternal Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. fateme.shojai@gmail.com.
Azam ErfanifarDepartment of Endocrinology, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Saeid KalbasiDepartment of Clinical Endocrinology, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Shahriar NikpourGastroenterology and Hepatology, Department of Adult Gastroenterology and Hepatology, School of Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Latif GachkarInfectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe effects of Empagliflozin on liver health in patients with Type 2 Diabetes Mellitus (T2DM) have not been fully elucidated. This study aimed to assess the impact of Empagliflozin on liver steatosis and related biomarkers in T2DM patients.

methodsA before-after clinical trial was conducted with 119 T2DM patients aged 20 to 70 with fatty liver, recruited from Laghman Hakim Hospital, Tehran, Iran. Participants were administered Empagliflozin for 6 months, with clinical and laboratory assessments conducted at baseline, 3 months, and 6 months. Liver function was evaluated through blood tests and imaging, including ultrasound and Magnetic resonance imaging (MRI), to assess hepatic steatosis. Biomarkers such as HbA1c, fasting blood glucose, insulin, lipid profile, and liver enzymes were measured. Insulin resistance was estimated using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) formula. Data were analyzed using SPSS 26 and STATA 14.

resultsA total of 119 patients (Intervention (N = 69), Control (N = 50)) were participated. The intervention group demonstrated a significant reduction in liver fat grade compared to the control group, with 17.5% of patients showing a reduction from grade 3 to grade 1 on MRI and 6% in the control group. The odds of worsening fatty liver in the control group were 48 times higher (95% CI: 15.5, 148.5) on MRI and 52 times higher (95% CI: 15.2, 178.1) on ultrasound, compared to the intervention group (NNT = 2). After 6 months, the intervention group showed significantly lower risks for ALT (RR: 0.72, 95% CI: 0.62-0.84), AST, and alkaline phosphatase (Alkp) abnormalities. Liver enzyme levels (ALT, AST, GGT) and systolic blood pressure (SBP) decreased significantly in the Empagliflozin group, with mean differences of -15.33 (95% CI: -18.8, -11.88) for ALT, -12.82 (95% CI: -15.5, -10.13) for AST, and - 6.31 (95% CI: -8.65, -3.97) for systolic blood pressure (SBP).

conclusionThese findings suggest that Empagliflozin could be an effective adjunctive therapy for managing liver dysfunction in T2DM patients with NAFLD.

trial registrationRegistered retrospectively in the Iranian Registry of Clinical Trials (IRCT20210811052150N1) on April 16,2023 Access at https://irct.behdasht.gov.ir/search/result?query=IRCT20210811052150N1 .

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesNon-alcoholic Fatty Liver DiseaseSodium-Glucose Transporter 2 InhibitorsAdultAgedBiomarkersBlood GlucoseFemaleFollow-Up StudiesHumansInsulin ResistanceIranMaleMiddle AgedBenzhydryl CompoundsBiomarkersBlood GlucoseempagliflozinGlucosidesSodium-Glucose Transporter 2 InhibitorsEmpagliflozinLiver dysfunctionNon-alcoholic fatty liverType 2 diabetes mellitus

Identifiers

PMID40011855
PMCPMC11863618

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.