Renoprotective effects of ursodeoxycholic acid

Not Applicable

• Conditions: Specialty: Diabetes, Primary sub-specialty: Both; UKCRC code/ Disease: Renal and Urogenital/ Renal failure; Urological and Genital Diseases; Renal failure

• Registration Number: ISRCTN14333327
• Lead Sponsor: King’s College London and Guy’s and St Thomas’ NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-26
• Last Update Posted: 24 May 2021
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. T1DM patients aged 20 to 75 years, with residual macroalbuminuria
2. Estimated GFR =3 ml/min
3. Written informed consent to participate in the study prior to any study procedures
4. Ability to communicate and comply with all study procedures

Exclusion Criteria

1. History of intolerance to Ursodeoxycholic acid
2. Active gastrointestinal disease (such as gall stones, inflammatory bowel disease, primary sclerosing cholangitis)
3. Non-diabetic renal disease
4. Absence of diabetic retinopathy
5. Pregnancy or lactation (female participants)
6. Insufficient understanding of the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Albumin excretion rate (AER) is measured using a standard laboratory test on three non-consecutive timed overnight urine specimens collected one week prior to visit at baseline and 24 weeks for each treatment period.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Brachial blood pressure is measured using an automated sphygmomanometer at baseline and 24 weeks<br> 2. Central aortic blood pressure and Ao-PWV are measured using applanation tonometry… at baseline and 24 weeks<br> 3. Glycated haemoglobin (HbA1c) is measured using blood test at baseline and 24 weeks<br> 4. Plasma albumin is measured using blood test at baseline and 24 weeks<br> 5. Liver function is measured using blood test at baseline and 24 weeks<br> 6. Urine electrolytes are measured using urine test at baseline and 24 weeks<br> 7. Endothelial and renal markers are measured using blood tests and flow mediated dilation at baseline and 24 weeks<br>