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

Urinary Albumin Excretion Clinical Trial

Official title:

Urinary Albumin Excretion in Women With Polycyclic Ovary Syndrome and it's Relation to Cardiovascular Risk Factors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02569164
• Other study ID #: kasrelaini Obgyn..
• Status: Not yet recruiting
• Phase: N/A
• First received: August 26, 2015
• Last updated: October 5, 2015
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: Kasr El Aini Hospital
• Contact: suzy abdelaziz, M.D.
• Phone: 01003726195
• Email: suzyabdelaziz92[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• PCO patients

Exclusion Criteria:

• pregnancy

• diabetes

• hypertension

• adrenal dysfunction

• thyroid dysfunction

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Urinary Albumin Excretion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with hyperinsulinemia (uIU/ml)		3 months	Yes
Primary	Number of patients with hyperlipidemia (mg/dl).		3 months	Yes
Primary	Number of patients with albuminuria(ug/ml)		3 months	Yes