| Trial ID: | L0683 |
| Source ID: | EUCTR2008-006928-55-GB
|
| Associated Drug: |
Exenatide
|
| Title: |
Are early and late cardiovascular risk markers in women with Polycystic Ovary Syndrome increased with concomitant Nonalcoholic Steatohepatitis and can this be modified with Exenatide? - CV risk in PCOS and NASH
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Women with polycystic ovary syndrome and nonalcoholic steatohepatitis
|
| Interventions: |
<br>Trade Name: Byetta 5 microgram solution for injection<br>Pharmaceutical Form: Solution for injection<br><br>Trade Name: byetta, 10 micrograms for injection, pre filled pen<br>Pharmaceutical Form: Solution for injection<br><br>
|
| Outcome Measures: |
Main Objective: 1. To show that the combination of Polycystic Ovary Syndrome (PCOS) and Nonalcoholic steatohepatitis (NASH) significantly amplifies cardiovascular risk markers compared to either PCOS or NASH alone.<br>2. To show that intervention with Exenatide significantly improves insulin resistance (an adverse cardiovascular risk marker)<br>;Primary end point(s): Improvement in endothelial function<br>Improvement in fibrin clot structure and function<br>Improvement in imflammation by Fibroscan measurement;Secondary Objective: 1. To show that intervention with Exenatide significantly improves endothelial function (Early manifestation of cardiovascular disease) in subjects with Polycystic Ovary Syndrome (PCOS) and Nonalcoholic Steatohepatitis (NASH)<br>2. To determine if Exenatide therapy significantly improves fibrin clot structure and function (Late manifestation of cardiovascular disease) in subjects with PCOS and NASH.<br>3. To determine if Exenatide is effective in reducing steatohepatitis by Fibroscan and reduces the markers of liver fibrosis<br>nan
|
| Sponsor/Collaborators: |
Hull and East Yorkshire NHS Trust
|
| Gender: |
Female
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| Enrollment: |
--
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Other specify the comparator: Comparing PCOS, PCOS
|
| Start Date: |
15/04/2009
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
19 March 2012
|
| Locations: |
United Kingdom
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006928-55
|
