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?

Not Applicable

Completed

• Conditions: Polycystic ovary syndrome, non-alcoholic steatohepatitis; Nutritional, Metabolic, Endocrine; Ovarian dysfunction

• Registration Number: ISRCTN81902209
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31001199 [added 26/04/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-13
• Study Completion: 2010-09-30
• Last Update Posted: 13 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

For PCOS:
1. Polycystic ovary syndrome (defined by the Rotterdam criteria as 2 out of 3 of:
1.1. Oligo/anovulation
1.2. Clinical or biochemical evidence of hirsuitism, and/or
1.3. Polycystic ovaries on ultrasound
2. Raised alanine aminotransferase (ALT)
3. Female, age 16-45 years

For NASH:
1. Patients with confirmed NASH
2. Female
3. Age 16-45 years

Exclusion Criteria

1. Ketoacidosis
2. Severe gastrointestinal disease
3. Type 2 diabetes
4. Hypothyroidism
5. Subjects taking regular prescribed medication
6. Not using a reliable method on contraception (eg barrier/oral contraceptive pill)
7. Patients not allowing disclosure to their GP's
8. History of pancreatitis
9. Chronic renal failure (creatinine clearance less than 60 ml/min or plasma creatinine >150 umol/L)
10. Pregnancy or breastfeeding women
11. Liver function tests >300% reference range normal (e.g., ALT >90 u/mL)
12. Acute conditions with the potential to alter renal function such as:
12.1. Dehydration
12.2. Severe infection
12.3. Shock
12.4. Intravascular administration of iodinated contrast

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<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>

Secondary Outcome Measures

Name	Time	Method
<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>