The renoprotective effects of Ursodeoxycholic acid in patients with type 1 diabetes and albuminuria

Phase 1

• Conditions: Type 1 diabetes; MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-003609-41-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-13
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

- T1DM patients aged 20 to 75 years, with residual albuminuria (defined as an urine albumin to creatinine ratio >3 mg/mmol) or proteinuria in the preceding 6 months on a maximum tolerated and stable dose of RAAS blockade (ACE-inhibitor or angiotensin receptor blocker-ARB).
- Estimated GFR (by MDRD equation) =30 ml/min.
- Written informed consent to participate in the study prior to any study procedures.
- Ability to communicate and comply with all study requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- History of intolerance to Ursodeoxycholic acid.
- Active gastrointestinal disease (such as gall stones, inflammatory bowel disease, primary sclerosing cholangitis).
- Non-diabetic renal disease.
- Absence of diabetic retinopathy (as this would suggest non diabetic renal disease).
- Pregnancy.
- Insufficient understanding of the trial
- Lactating females

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate if Ursodeoxycholic acid reduces albuminuria in patients with type 1 diabetes mellitus (T1DM) with residual albuminuria despite established standard care. ;Secondary Objective: To evaluate if Ursodeoxycholic acid improves n vascular , metabolic and renal measures / function excretion<br>;Primary end point(s): Change in albumin excretion rate (AER) after 24 weeks treatment with Ursodeoxycholic acid as compared to 24 weeks on placebo;Timepoint(s) of evaluation of this end point: After 24 and 48 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in endothelial function and permeability Change in serum electrolytes (sodium, potassium), and renal function/estimated GFR <br>Change in brachial blood pressure.<br>Change in central aortic blood pressure and Ao-PWV.<br>Change in HbA1c, lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides).<br>Change in plasma albumin and liver function tests (ALT, ALP GGT).<br>Change in 24 hours urine sodium, urine magnesium, uric acid, calcium and phosphate, potassium<br>excretion.<br>Change in endothelial and renal injury markers; hsCRP, VCAM, ET-1, vWF, oxLDL, Interleukin 6,<br>Interleukin 1-beta, Interleukin 18, NGAL, KIM-1 and LFABP.<br>Change in levels of circulating serum levels of Ursodeoxycholic acid and other bile acids (including cholic acid,deoxycholicacid, chenodeoxycholic acid, lithocholic acid)<br>;Timepoint(s) of evaluation of this end point: 48 weeks