PMID- 38455850 OWN - NLM STAT- MEDLINE DCOM- 20240311 LR - 20240424 IS - 2314-6753 (Electronic) IS - 2314-6745 (Print) VI - 2024 DP - 2024 TI - 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. PG - 4187796 LID - 10.1155/2024/4187796 [doi] LID - 4187796 AB - 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 (p = 0.024) and in diastolic blood pressure (p = 0.033), compared to placebo. In addition, there was a statistically significant difference in waist circumference in the UDCA group before and after treatment (p < 0.05). Although no statistical significance was observed at the two-month follow-up assessment, an average decrease in glucose levels in the UDCA group was observed. After two months of the intervention period, a significant decrease in the activity of liver enzymes was noticed. Furthermore, a significant reduction in prooxidative parameters (TBARS, NO(2)(-), H(2)O(2)) and significant elevation in antioxidative parameters such as SOD and GSH were found (p < 0.001). 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. CI - Copyright (c) 2024 Biljana Lakic et al. FAU - Lakic, Biljana AU - Lakic B AUID- ORCID: 0000-0002-4327-6141 AD - Department of Family Medicine, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina. AD - Primary Health Care Centre, Banja Luka, Bosnia and Herzegovina. FAU - Skrbic, Ranko AU - Skrbic R AUID- ORCID: 0000-0002-6643-1781 AD - Department of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina. AD - Centre for Biomedical Research, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina. FAU - Uletilovic, Snezana AU - Uletilovic S AD - Department of Medical Biochemistry and Chemistry, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina. FAU - Mandic-Kovacevic, Nebojsa AU - Mandic-Kovacevic N AD - Department of Pharmacy, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina. FAU - Grabez, Milkica AU - Grabez M AUID- ORCID: 0000-0002-7770-6293 AD - Department of Hygiene, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina. FAU - Saric, Mirna Popovic AU - Saric MP AD - Primary Health Care Centre, Banja Luka, Bosnia and Herzegovina. FAU - Stojiljkovic, Milos P AU - Stojiljkovic MP AUID- ORCID: 0000-0001-9431-0736 AD - Department of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina. AD - Centre for Biomedical Research, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina. FAU - Soldatovic, Ivan AU - Soldatovic I AD - Institute of Medical Statistics and Informatics, Faculty of Medicine, University of Belgrade, Belgrade, Serbia. FAU - Janjetovic, Zorica AU - Janjetovic Z AUID- ORCID: 0000-0001-6108-2212 AD - Department of Dermatology, University of Alabama at Birmingham, Birmingham, AL, USA. FAU - Stokanovic, Anastasija AU - Stokanovic A AD - Primary Health Care Centre, Banja Luka, Bosnia and Herzegovina. FAU - Stojakovic, Natasa AU - Stojakovic N AD - Department of Pharmacology, Toxicology and Clinical Pharmacology, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina. FAU - Mikov, Momir AU - Mikov M AD - Centre for Biomedical Research, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina. LA - eng SI - ClinicalTrials.gov/NCT05416580 PT - Journal Article PT - Randomized Controlled Trial DEP - 20240229 PL - England TA - J Diabetes Res JT - Journal of diabetes research JID - 101605237 RN - IY9XDZ35W2 (Glucose) RN - BBX060AN9V (Hydrogen Peroxide) RN - 724L30Y2QR (Ursodeoxycholic Acid) SB - IM MH - Humans MH - *Diabetes Mellitus, Type 2/drug therapy MH - Glucose MH - Hydrogen Peroxide MH - Oxidative Stress MH - Prospective Studies MH - *Ursodeoxycholic Acid/therapeutic use PMC - PMC10919985 COIS- The authors declare that they have no conflicts of interest. EDAT- 2024/03/08 06:42 MHDA- 2024/03/11 06:43 PMCR- 2024/02/29 CRDT- 2024/03/08 04:05 PHST- 2023/11/10 00:00 [received] PHST- 2024/01/15 00:00 [revised] PHST- 2024/02/15 00:00 [accepted] PHST- 2024/03/11 06:43 [medline] PHST- 2024/03/08 06:42 [pubmed] PHST- 2024/03/08 04:05 [entrez] PHST- 2024/02/29 00:00 [pmc-release] AID - 10.1155/2024/4187796 [doi] PST - epublish SO - J Diabetes Res. 2024 Feb 29;2024:4187796. doi: 10.1155/2024/4187796. eCollection 2024.