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
- Conditions
- Women with polycystic ovary syndrome and nonalcoholic steatohepatitis
- Registration Number
- EUCTR2008-006928-55-GB
- Lead Sponsor
- Hull and East Yorkshire NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method