2026-10-11T18:21:09Z https://api.figshare.com/v2/oai

oai:figshare.com:article/33994075 2026-09-25T08:39:16Z category_658 portal_316 item_type_3 month_year_09_2026

Table 1_The effects of ursodeoxycholic acid on albuminuria in people with type 1 diabetes and diabetic kidney disease: a proof-of-concept study.docx Nikolaos Fountoulakis (5800487) Panagiotis Pavlou (22519733) Luigi Gnudi (185070) Giuseppe Maltese (13886211) Angeliki Panagiotou (13886208) Salma Ayis (618105) Fowzia Ibrahim (63639) Janaka Karalliedde (185076) Cell Metabolism albuminuria clinical trial diabetic kidney disease type 1 diabetes ursodeoxycholic acid Introduction<p>In animal models of diabetic kidney disease (DKD), ursodeoxycholic acid (UDCA) reduces albuminuria and improves histological changes associated with DKD. The purpose of this study was to investigate the potential renoprotective role of UDCA in people with type 1 diabetes (T1D) and DKD.</p>Methods<p>In this single-centre, double-blind, placebo-controlled crossover trial, participants with T1D and DKD with residual albuminuria (urine albumin to creatinine ratio, > 3 mg/mmol) on a maximum tolerated, stable dose of renin–angiotensin system (RAS) blockade with estimated glomerular filtration rate (eGFR) ≥ 30 ml/min were included. Participants were randomly allocated to UDCA (500 mg BID) or placebo for 24 weeks, with a 4-week washout period in between. The primary endpoint was the change in urine albumin excretion rate (UAER), measured from timed urine collections after 24 weeks of treatment with UDCA compared with placebo.</p>Results<p>Thirty-one participants were included, of whom 21 were men; the median age (interquartile range [IQR]) was 54.2 (22.7–75.3) years. The baseline median (IQR) UAER was 26 (12.3–189.0) μg/min for UDCA and 32.1 (19.9–88.2) μg/min for placebo. The median (IQR) posttreatment UAER was 36.2 (14.9–174.0) μg/min for UDCA and 38.5 (17.6–194.0) μg/min for placebo, with no significant difference in UAER between treatments (p-value = 0.4).</p>Conclusion<p>In this first-ever human study investigating the potential renoprotective effect of UDCA treatment for 24 weeks in people with T1D and DKD, we did not observe a significant reduction in UAER. Further studies are required to evaluate the role of UDCA in DKD.</p>Clinical trial registration<p>https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003609-41, identifier 2015-003609-41.</p> 2026-09-25T08:39:16Z Dataset Dataset 10.3389/fendo.2026.1908356.s001 https://figshare.com/articles/dataset/Table_1_The_effects_of_ursodeoxycholic_acid_on_albuminuria_in_people_with_type_1_diabetes_and_diabetic_kidney_disease_a_proof-of-concept_study_docx/33994075 CC BY 4.0