Do women with polycystic ovary syndrome have increased cardiovascular risk compared to normal controls and could this risk be reduced by liraglutide?

Are early and late cardiovascular risk markers in women with polycystic ovary syndrome increased with concomitant non-alcoholic steatohepatitis and can this be modified with liraglutide?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN48560305

Enrollment

Registered

2012-05-22

Start date

2010-05-24

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Polycystic Ovary Syndrome Nutritional, Metabolic, Endocrine Polycystic ovarian syndrome

Interventions

Women with PCOS were diagnosed according to the Rotterdam criteria. Other endocrine disorders with similar presentation were excluded. Normal control women underwent similar tests to rule out any unkn

Eligibility

Sex/Gender

Female

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 and the exclusion of other disorders 4. Age 18-45 years For normal controls: 1. Female, aged 18 - 45 2. Body madd index (BMI) 30 - 45 3. No current medical problems

Exclusion criteria

Exclusion criteria: 1. Ketoacidosis 2. Severe gastrointestinal disease 3. Hypothyroidism 4. Subjects taking regular medications associated with high risk of hepatotoxicity like isoniazid and methotrexate 5. Not using a reliable method of contraception 6. Patients not allowing disclosure to their GP's 7. History of pancreatitis 8. Heart Failure 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 (eg ALT>90 u/mL) 12. Type 2 diabetes mellitus 13. Acute conditions with the potential to alter renal function such as: dehydration / severe infection / shock / intravascular administration of iodinated contrast

Design outcomes

Primary

Measure	Time frame
Improvement in cIMT and platelet function measured at baseline and after 6 months treatment with Liraglutide	—

Secondary

Measure	Time frame
1. Improvement in endothelial function will be measured using EndoPat 2000 at baseline, 3, 6 and 9 months of treatment 2. Liver fibrosis markers were measured at baseline, 3, 6 and 9months of treatment 3. Depression [Centre for Epidemiologic Studies Depression Scale (CES-D)] at baseline and after 6 months of treatment with liraglutide 4. Quality of life will be measured using WHO QoL questionaire at baseline and after 6 months of treatment with liraglutide	—

Measure

Time frame

1. Improvement in endothelial function will be measured using EndoPat 2000 at baseline, 3, 6 and 9 months of treatment 2. Liver fibrosis markers were measured at baseline, 3, 6 and 9months of treatment 3. Depression [Centre for Epidemiologic Studies Depression Scale (CES-D)] at baseline and after 6 months of treatment with liraglutide 4. Quality of life will be measured using WHO QoL questionaire at baseline and after 6 months of treatment with liraglutide

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026