| Trial ID: | L0690 |
| Source ID: | EUCTR2007-004515-56-AT
|
| Associated Drug: |
Ursodeoxycholic acid
|
| Title: |
Efficacy of ursodeoxycholic acid in the treatment of insulin resistance and vascular dysfunction in non-alcoholic fatty liver disease
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic fatty liver disease (NAFLD)
|
| Interventions: |
<br>Trade Name: Ursofalk<br>Product Name: Ursodeoxycholic acid<br>Pharmaceutical Form: Capsule*<br>INN or Proposed INN: Ursodeoxycholic acid<br>Pharmaceutical form of the placebo: Capsule*<br>Route of administration of the placebo: Oral use<br><br>
|
| Outcome Measures: |
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)nan
|
| Sponsor/Collaborators: |
Klinische Abteilung f??r Gastroenterologie und Hepatologie, Medizinische Universit??tsklinik, MUG
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Phase 3
|
| Enrollment: |
110
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>
|
| Start Date: |
25/03/2008
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
26 October 2020
|
| Locations: |
Austria
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004515-56
|
