Metformin improves arterial stiffness in polycystic ovary syndrome (PCOS)

Not Applicable

Completed

• Conditions: Nutritional, Metabolic, Endocrine; Ovarian dysfunction; Polycystic ovary syndrome

• Registration Number: ISRCTN61785174
• Lead Sponsor: Cardiff University (UK)

Brief Summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19996308

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-05-01
• Study Start: 2009-06-25
• Last Update Posted: 2 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

1. From the Endocrinology clinics at the University Hospital of Wales
2. Diagnosed with PCOS, based on androgen excess (clinical symptoms of hyperandrogenism and/or elevated testosterone) with ovulatory dysfunction (fewer than six menstrual cycles per year), supported by ovarian ultrasound where available
3. Congenital adrenal hyperplasia, Cushings syndrome, androgen-secreting neoplasms, hyperprolactinaemia and thyroid disease excluded by biochemical testing
4. Aged between 18 and 35 years

Exclusion Criteria

1. Pregnant
2. Breastfeeding
3. History of current or previous use (within 6 months) of oral contraceptives, anti-diabetics or anti-androgens
4. Contraindications to metformin therapy including renal or hepatic impairment, ketoacidosis, or conditions where tissue hypoxia is likely (e.g. sepsis, respiratory failure, recent myocardial infarction)
5. History of hypertension or diabetes
6. Able to use barrier methods of contraception if sexually active. In addition, pregnancy tests were performed at each study visit and patients were withdrawn from the study in the event of confirmed pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in measures of arterial stiffness (pulse wave velocity and augmentation index as measured by pulse wave analysis post-salbutamol versus post-GTN) from baseline, recorded at enrolment and then repeated at 12 weeks, 20 weeks and 32 weeks.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Changes in testosterone, plasminogen activator inhibitor-1 (PAI-1), endothelin-1 (ET-1) and high sensitivity C-reactive protein (hsCRP)<br> 2. Measures of insulin resistance<br> 3. Lipid profile<br><br> Recorded at enrolment and then repeated at 12 weeks, 20 weeks and 32 weeks.<br>