Cardiovascular Risks and Urinary Albumin Excretion(UAE) i... | NCT02569164

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

NCT02569164

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Oct 6, 2015Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Urinary Albumin Excretion

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Nov 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Aug 26, 2015

First Submission Date that Met QC Criteria

Oct 5, 2015

First Posted Date

Oct 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2015

Last Update Posted Date

Oct 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PCO patients

Exclusion Criteria:

pregnancy
diabetes
hypertension
adrenal dysfunction
thyroid dysfunction

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

PCO patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
suzy abdelaziz, M.D.	Contact	01003726195		suzyabdelaziz92@gmail.com

Overall Officials

Name	Affiliation	Role
suzy abdelaziz, M.D.	kasrelaini	Principal Investigator

Locations

Not provided