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.

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, NO2-, H2O2) 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.

Comparison of Jaffe Method and Enzymatic Method at Measuring Serum Creatinine Level, Creatinine Clearance and Estimated Glomerular Filtration Rate.

Background: Correct measuring of blood and urine creatinine level is necessary for identification and tracking of chronic kidney disease (CKD). Objective: The aim of this study is a comparison of Jaffe and enzymatic methods for measuring creatinine in serum and in urine, in order to determine whether there are any statistical significant differences between them, and whether they are reflected on creatinine clearance calculation and estimated glomerular filtration rate (eGFR). Methods: Creatinine in serum and urine was measured for the group of patients (N=60; female=34, male=26) from 24 to 69 years of age by using Jaffe's method on Dimension RxL biochemical analyzer, and enzymatic method on integrated biochemical and immunochemical analyzer Architect ci8200, and obtained levels are used for creatinine clearance calculation and eGFR. Results: The methods correlate well, both in measuring serum creatinine (r 1 = 0.990) and in measuring urine creatinine (r 2 =0.974). There are no statistically significant differences between them (p=0.57). Measuring creatinine using different methods showed no statistically significant differences in the calculated clearances (p=0.93), they significantly correlate (r=0.9722). eGFR, using the MDRD and CKD-EPI formulas, were not statistically significantly different, regardless of the used method. Conclusion: Apart from significant correlations between the used methods, the results of using the Jaffe and enzymatic methods showed no significant differences at measuring serum creatinine level, or creatinine clearance and glomerular filtration rate.