Women with polycystic ovary syndrome and nonalcoholic steatohepatitis
Conditions
Interventions
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Sponsors
Hull and East Yorkshire NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For PCOS: Polycystic ovary syndrome (defined by the Rotterdam criteria as 2 out of 3 of: 1. oligo/anovulation 2. clinical or biochemical evidence of hirsuitism, and/or 3. polycystic ovaries on ultrasound. Raised alanine aminotransferase Age 16-45 years For NASH: Patients with confirmed NASH Female Age 16-45 years 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Type 2 diabetes Hypothyroidism Subjects taking regular prescribed medication Not using a reliable method on contraception (eg barrier/oral contraceptive pill) Patients not allowing disclosure to their GP’s. History of pancreatitis Chronic renal failure (creatinine clearance less than 60 ml/min or plasma creatinine >150 umol/L) Pregnancy or breastfeeding women Liver function tests >300% reference range normal (eg ALT>90 u/mL) Acute conditions with the potential to alter renal function such as: a. dehydration b. severe infection c. shock d. intravascular administration of iodinated contrast
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2. To show that intervention with Exenatide significantly improves insulin resistance (an adverse cardiovascular risk marker) ;Primary end point(s): Improvement in endothelial function Improvement in fibrin clot structure and function 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) 2. To determine if Exenatide therapy significantly improves fibrin clot structure and function (Late manifestation of cardiovascular disease) in subjects with PCOS and NASH. 3. To determine if Exenatide is effective in reducing steatohepatitis by Fibroscan and reduces the markers of liver fibrosis | — |
Countries
United Kingdom
Outcome results
None listed