| Trial ID: | L0682 |
| Source ID: | ISRCTN81902209
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| Associated Drug: |
Exenatide
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| Title: |
Are early and late cardiovascular risk markers in women with polycystic ovary syndrome (PCOS) increased with concomitant non-alcoholic steatohepatitis (NASH) and can this be modified with exenatide?: An interventional open parallel single-centre trial
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
Has Results
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| Results: |
--
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| Conditions: |
Polycystic ovary syndrome, non-alcoholic steatohepatitis <br>Nutritional, Metabolic, Endocrine <br>Ovarian dysfunction
|
| Interventions: |
<br> Twelve patients will be recruited for each of the three groups: 1) PCOS only, 2) NASH only and 3) PCOS with NASH (total n = 36).<br><br> Exenatide 5 mcg subcutaneously (sc) twice a day (bd) for 1 month then exenatide 10
|
| Outcome Measures: |
<br> 1. To show that the combination of PCOS and 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><br> All primary and secondary outcomes will be assessed in September 2010.<br> <br> 1. To show that intervention with exenatide significantly improves endothelial function (Early manifestation of cardiovascular disease) in subjects with PCOS and 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><br> All primary and secondary outcomes will be assessed in September 2010.<br>
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| Sponsor/Collaborators: |
Hull and East Yorkshire Hospitals NHS Trust (UK)
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| Gender: |
Female
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| Age: |
nannan
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| Phases: |
Not applicable
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| Enrollment: |
36
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| Study Type: |
Interventional
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| Study Designs: |
Interventional open parallel single-centre trial (Treatment)
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| Start Date: |
13/05/2009
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| Completion Date: |
30/09/2010
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| Results First Posted: |
--
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| Last Update Posted: |
13 May 2019
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| Locations: |
United Kingdom
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| URL: |
http://isrctn.com/ISRCTN81902209
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