Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2527
Source ID: NCT05416580
Associated Drug: Udca (Ursodeoxycholic Acid)
Title: Efficacy of Ursodeoxycholic Acid (UDCA) in Patients With Type 2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: UDCA (Ursodeoxycholic acid)|DRUG: Placebo|DRUG: Metformin
Outcome Measures: Primary: Change in oxidative stress biomarkers levels: superoxide dismutase (SOD), catalase, and malondialdehyde (MDA), ELISA assay (same units), From Baseline and after 8 weeks|Change in pro-inflammatory markers concentrations: tumor necrosis factor-α (TNF-α), and interleukin 6 (IL-6), ELISA assay (same units), From Baseline and after 8 weeks|Change in serum levels of homocystein, Detection by fluorescence polarization immunoassay, From Baseline and after 8 weeks|Change in serum levels of von Willebrand factor (vWF), Intercellular Adhesion Molecule 1 (ICAM-1), Vascular Adhesion Molecule 1 (VCAM-1), and fibrinogen, ELISA assay (same units), From Baseline and after 8 weeks|Change in serum levels of Vitamin D and Folic acid, Microparticle enzyme immunoassay (same units), From Baseline and after 8 weeks|Change in Total antioxidant capacity (TAC) level, Results expressed in units μg/ml Trolox equivalents, From Baseline and after 8 weeks|Change in inflammation marker level: high sensitivity CRP, Turbid metric test, From Baseline and after 8 weeks | Secondary: Change in Haemoglobin A1C (HbA1C), HbA1C level will be expressed in %, From Baseline and after 8 weeks|Change in Total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides, Clinical biochemistry (colorimetric) tests, and results will be expressed in mmol/L (same units), From Baseline and after 8 weeks|Change in body weight, Weight (kg), From Baseline and after 8 weeks
Sponsor/Collaborators: Sponsor: University of Banja Luka
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-09-12
Completion Date: 2024-04
Results First Posted:
Last Update Posted: 2023-05-11
Locations: Public Health Institution Dom zdravlja Banja Luka, Banja Luka, Republic Of Srpska, 78000, Bosnia and Herzegovina
URL: https://clinicaltrials.gov/show/NCT05416580