NCT05416580

Efficacy of Ursodeoxycholic Acid (UDCA) in Patients With Type 2 Diabetes

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Banja Luka · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of ursodeoxycholic acid (UDCA) compared to placebo on biomarkers of oxidative stress, inflammation, and endothelial dysfunction in patients with type 2 diabetes mellitus (T2DM) who are treated with metformin but did not meet the target HbA1C \< 7%.

Detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, evaluation of the efficacy of UDCA on oxidative stress, inflammation, and endothelial dysfunction in combination with metformin after 8 weeks in patients with T2DM who did not meet HbA1C \< 7%. Study site: a single study center (Primary Health Care Institution in Banja Luka, as recruiter center) including Center for Biomedical Research, Faculty of Medicine University of Banja Luka, as reference coordinator and research center. Sample size : 60 patients, randomized in a 1:1 allocation ratio. Objectives 1. To investigate the effects of UDCA added to metformin on glycemia, HbA1C, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), lipoproteins, and body mass index. 2. To investigate whether UDCA has an impact on lipid peroxidation index, nitric oxide metabolites, hydrogen peroxide (H2O2), superoxide anion radical (O2-), and total antioxidant capacity. 3. To investigate whether UDCA has an impact on the dynamic of inflammatory markers interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and high sensitive CRP (hsCRP). 4. To investigate whether UDCA has an impact on von Willebrand factor (vWF), Intercellular Adhesion Molecule 1 (ICAM-1), Vascular Adhesion Molecule 1 (VCAM-1), fibrinogen, homocysteine, folic acid, and vitamin D levels. Treatments arms: UDCA (1500 mg/day) + Metformin (maximum tolerated daily dose) UDCA placebo + Metformin (maximum tolerated daily dose) Treatment duration : 8 weeks Assessment - clinical and laboratory sampling: Informed consent and Screening - 7 days prior to randomization Study visits (V): V1 - Randomization and Enrollment (Baseline) V2 - 4 weeks after Baseline V3 - 8 weeks after Baseline. No interim analysis is planned. The analysis will be performed at the end of the study after data review and freezing of the database according to the intent to treat principle.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	UDCA (Ursodeoxycholic acid)	UDCA is administered orally in addition to metformin therapy in the recommended doses in patients with type 2 diabetes mellitus.
DRUG	Placebo	Placebo is administered orally in addition to metformin therapy in the recommended doses in patients with type 2 diabetes mellitus.
DRUG	Metformin	Metformin therapy is administered in the recommended dose in patients with type 2 diabetes mellitus.

Timeline

• Start date: 2022-09-12
• Primary completion: 2024-03-01
• Completion: 2024-04-01
• First posted: 2022-06-13
• Last updated: 2023-05-11

Locations

1 site across 1 country: Bosnia and Herzegovina