Are early and late cardiovascular risk markers in women with Polycystic Ovary Syndrome increased with concomitant Nonalcoholic Steatohepatitis and can this be modified with Liraglutide?

Phase 1

• Conditions: MedDRA version: 12.0 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome; MedDRA version: 12.0 Level: LLT Classification code 10053219 Term: Non-alcoholic steatohepatitis; Polycystic Ovary Syndrome Non-alcoholic Steatohepatitis

• Registration Number: EUCTR2009-015927-94-GB
• Lead Sponsor: Hull and East Yorkshire NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Study Completion: 2013-01-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.
and exclusion of other disorders

Age 18-45 years
For NASH:
Patients with confirmed NASH
Female
Age 18-45 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

Ketoacidosis
Severe gastrointestinal disease
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
Heart Failure
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)
Type 2 Diabetes Mellitus
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