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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004515-56-AT

Enrollment

110

Registered

2008-03-25

Start date

2008-04-28

Completion date

Unknown

Last updated

2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease (NAFLD)

Interventions

Trade Name: Ursofalk Product Name: Ursodeoxycholic acid Pharmaceutical Form: Capsule* INN or Proposed INN: Ursodeoxycholic acid Pharmaceutical form of the placebo: Capsule* Route of administration of

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026