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

October 5, 2015 updated by: suzy abdelaziz Abdelhamid, Kasr El Aini Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

PCO patients

Description

Inclusion Criteria:

  • PCO patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with hyperinsulinemia (uIU/ml)
Time Frame: 3 months
3 months
Number of patients with hyperlipidemia (mg/dl).
Time Frame: 3 months
3 months
Number of patients with albuminuria(ug/ml)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: suzy abdelaziz, M.D., kasrelaini

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 6, 2015

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • kasrelaini Obgyn..

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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