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?

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81902209

Enrollment

Registered

2009-05-13

Start date

2009-05-01

Completion date

Unknown

Last updated

2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome, non-alcoholic steatohepatitis Nutritional, Metabolic, Endocrine Ovarian dysfunction

Interventions

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). Exenatide 5 mcg subcutaneously (sc) twice a day (bd) f

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. To show that the combination of PCOS and 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) All primary and secondary outcomes will be assessed in September 2010.	—

Secondary

Measure	Time frame
1. To show that intervention with exenatide significantly improves endothelial function (Early manifestation of cardiovascular disease) in subjects with PCOS and 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 All primary and secondary outcomes will be assessed in September 2010.	—

Measure

Time frame

1. To show that intervention with exenatide significantly improves endothelial function (Early manifestation of cardiovascular disease) in subjects with PCOS and 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 All primary and secondary outcomes will be assessed in September 2010.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026