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

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ClinicalTrials.gov Identifier: NCT02569164
Recruitment Status : Unknown
Verified October 2015 by suzy abdelaziz Abdelhamid, Kasr El Aini Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 6, 2015
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
suzy abdelaziz Abdelhamid, 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.

Condition or disease
Urinary Albumin Excretion

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Urinary Albumin Excretion in Women With Polycyclic Ovary Syndrome and it's Relation to Cardiovascular Risk Factors
Study Start Date : October 2015
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of patients with hyperinsulinemia (uIU/ml) [ Time Frame: 3 months ]
  2. Number of patients with hyperlipidemia (mg/dl). [ Time Frame: 3 months ]
  3. Number of patients with albuminuria(ug/ml) [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
PCO patients
Criteria

Inclusion Criteria:

  • PCO patients

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569164


Contacts
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Contact: suzy abdelaziz, M.D. 01003726195 suzyabdelaziz92@gmail.com

Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: suzy abdelaziz, M.D. kasrelaini
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Responsible Party: suzy abdelaziz Abdelhamid, lecturer of Obgyn, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT02569164    
Other Study ID Numbers: kasrelaini Obgyn..
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015