Cardiovascular Risks and Urinary Albumin Excretion(UAE) in Polycystic Ovarian Syndrome (PCO)

• Conditions: Urinary Albumin Excretion

• Registration Number: NCT02569164
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

PCO patients will be assessed clinically,urine \& blood samples will be tested. Systolic \& diastolic blood pressure, serum glucose \& insulin levels, lipid profile, C-reactive protein, complete hormonal profile, and Urinary albumin excretion will be measured.

Detailed Description

PCO patients with 2 of 3 criteria: oligo- or anovulation ; hyperandrogenism \&polycystic ovaries. Exclusion criteria: pregnancy, diabetes, hypertension , adrenal \& thyroid dysfunction.

Blood samples after overnight fast (8hrs) at day 2 or 3 of menstrual cycle. Serum concentration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin, total testosterone \& sex hormone binding globulin, serum 17-hydroxy (OH) progesterone \& dehydroepiandrosterone sulfate will be measured.

Oral glucose tolerance test \& plasma insulin levels will be measured. Total cholesterol, triglycerides, high\& low density lipoproteins. Urinary albumin will be measured\& all the data will be analysed.

Study Timeline

• Study First Submitted: 2015-08-26
• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-05
• Last Update Submitted: 2015-10-05
• Study First Posted: 2015-10-06
• Last Update Posted: 2015-10-06
• Primary Completion: 2015-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• PCO patients

Exclusion Criteria

• pregnancy
• diabetes
• hypertension
• adrenal dysfunction
• thyroid dysfunction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with hyperinsulinemia (uIU/ml)	3 months
Number of patients with hyperlipidemia (mg/dl).	3 months
Number of patients with albuminuria(ug/ml)	3 months