Evidence map›Paper›PMID 38455850›Full record

Trial reportJournal of diabetes research2024

Beneficial Effects of Ursodeoxycholic Acid on Metabolic Parameters and Oxidative Stress in Patients with Type 2 Diabetes Mellitus: A Randomized Double-Blind, Placebo-Controlled Clinical Study.

Biljana Lakić, Ranko Škrbić, Snežana Uletilović, Nebojša Mandić-Kovačević, Milkica Grabež, Mirna Popović Šarić, Miloš P Stojiljković, Ivan Soldatović, Zorica Janjetović, Anastasija Stokanović and 2 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT05416580. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% of its field
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.

NCT05416580 phase3unknown status

Randomized, Double-blind, Placebo-controlled Study of Ursodeoxycholic Acid (UDCA) Therapy on Biomarkers of Oxidative Stress, Inflammatory and Endothelial Dysfunction in Patients With Type 2 Diabetes Mellitus

Ran2022Enrolled60Registered outcomes10Posted comparisons0ConditionsDiabetes Mellitus, Type 2ArmsMetformin, Placebo, UDCA (Ursodeoxycholic acid)
Open the trial in the graph
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
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  5. Review
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  11. Bile acids as therapeutic agents.Frontiers in pharmacology · 2025
    Review
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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

12 authors at 3 institutions in 3 countries.

Biljana LakićDepartment of Family Medicine, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.ORCID https://orcid.org/0000-0002-4327-6141
Ranko ŠkrbićDepartment of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.ORCID https://orcid.org/0000-0002-6643-1781
Snežana UletilovićDepartment of Medical Biochemistry and Chemistry, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.
Nebojša Mandić-KovačevićDepartment of Pharmacy, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.
Milkica GrabežDepartment of Hygiene, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.ORCID https://orcid.org/0000-0002-7770-6293
Mirna Popović ŠarićPrimary Health Care Centre, Banja Luka, Bosnia and Herzegovina.
Miloš P StojiljkovićDepartment of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.ORCID https://orcid.org/0000-0001-9431-0736
Ivan SoldatovićInstitute of Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
Zorica JanjetovićDepartment of Dermatology, University of Alabama at Birmingham, Birmingham, AL, USA.ORCID https://orcid.org/0000-0001-6108-2212
Anastasija StokanovićPrimary Health Care Centre, Banja Luka, Bosnia and Herzegovina.
Nataša StojakovićDepartment of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.
Momir MikovCentre for Biomedical Research, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina.
University of Banja Luka · BAUniversity of Alabama at Birmingham · USUniversity of Belgrade · RS

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Oxidative stress and inflammation are closely related pathophysiological processes, both occurring in type 2 diabetes mellitus (T2DM). In addition to the standard treatment of T2DM, a potential strategy has been focused on the use of bile acids (BAs) as an additional treatment. Ursodeoxycholic acid (UDCA), as the first BA used in humans, improves glucose and lipid metabolism and attenuates oxidative stress. The aim of this study was to evaluate the potential metabolic, anti-inflammatory, and antioxidative effects of UDCA in patients with T2DM. Methods: This prospective, double-blind, placebo-controlled clinical study included 60 patients with T2DM, randomly allocated to receive UDCA or placebo. Subjects were treated with 500 mg tablets of UDCA or placebo administered three times per day (total dose of 1500 mg/day) for eight weeks. Two study visits, at the beginning (F0) and at the end (F1) of the study, included the interview, anthropometric and clinical measurements, and biochemical analyses. Results: UDCA treatment showed a significant reduction in body mass index ( Conclusions: The eight-week UDCA administration showed beneficial effects on metabolic and oxidative stress parameters in patients with T2DM. Thus, UDCA could attenuate the progression and complications of diabetes and should be considered as an adjuvant to other diabetes treatment modalities. This trial is registered with NCT05416580.

Indexed as

Diabetes Mellitus, Type 2Ursodeoxycholic AcidGlucoseHumansHydrogen PeroxideOxidative StressProspective StudiesGlucoseHydrogen PeroxideUrsodeoxycholic Acid

Identifiers

PMID38455850
PMCPMC10919985
OpenAlexW4392365429

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.