Efficacy of ursodeoxycholic acid in the treatment of insulin resistance and vascular dysfunction in non-alcoholic fatty liver disease

Phase 1

• Conditions: on-alcoholic fatty liver disease (NAFLD)

• Registration Number: EUCTR2007-004515-56-AT
• Lead Sponsor: Klinische Abteilung für Gastroenterologie und Hepatologie, Medizinische Universitätsklinik, MUG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-25
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

- MS (NCEP ATP III): at least 3 of 5 risk factors (waist circumference in men >102 cm,
waist circumference in women >88 cm; triglycerides >150 mg/dL; HDL-C in men <40
mg/dL, HDL-C in women <50 mg/dL; blood pressure >130/85 mmHg or treated
hypertension; fasting glucose >110 mg/dL or treated diabetes mellitus)
- Diagnosis of NAFLD defined by the following criteria: alcohol consumption less than
30 g per day, liver histology compatible with NAFLD (steatosis more than 30% of
liver parenchyma)
- Male or female gender
- Age 18-70 years
- Signed informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Malignancy within the last five years
- Chronic liver disease other than NAFLD (viral hepatitis, autoimmune liver disease,
hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease)
- Drug-treated diabetes (insulin or other anti-diabetic drugs), end-organ damage
due to diabetes (e.g. proliferative retinopathy, renal glomerulosclerosis)
- BMI >40 kg/m2
- Inability or contraindications to perform study procedures
- Participation to other clinical trials in the previous 3 months
- Mycardial infarction in 6 months prior to enrollment
- Cerebrovascular events in 6 months prior to enrollment

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to determine whether high dose (25-30 mg/kg/d) UDCA improves IR in NAFLD;Secondary Objective: - to determine whether high dose (25-30 mg/kg/d) UDCA improves vascular <br> dysfunction in NAFLD<br>- to determine whether high dose (25-30 mg/kg/d) UDCA improves the histological <br> severity of NAFLD (degree of steatosis, inflammation, fibrosis) <br>- to determine whether the histological severity of NAFLD (degree of steatosis, <br> inflammation, fibrosis) correlates with IR and vascular dysfunction <br>- to determine whether high dose (25-30 mg/kg/d) UDCA improves alterations in <br> serum/hepatic adiponectin levels and hepatic ER stress;Primary end point(s): Insulin resistance (IR)