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

Not Applicable

Completed

Conditions: Polycystic Ovary Syndrome
Nutritional, Metabolic, Endocrine
Polycystic ovarian syndrome

Registration Number: ISRCTN48560305

Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 40

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in cIMT and platelet function measured at baseline and after 6 months treatment with Liraglutide

Secondary Outcome Measures

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