Urinary Albumin ExcretionNCT02569164
Cardiovascular Risks and Urinary Albumin Excretion(UAE) in Polycystic Ovarian Syndrome (PCO)
An observational study of Urinary Albumin Excretion, run by Kasr El Aini Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Urinary Albumin Excretion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: PCO patients
Who may be able to join
- PCO patients
Who cannot join
- pregnancy
- diabetes
- hypertension
- adrenal dysfunction
- thyroid dysfunction
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Albumin Excretion
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with hyperinsulinemia (uIU/ml)
Measured: 3 months
Number of patients with hyperlipidemia (mg/dl).
Measured: 3 months
Number of patients with albuminuria(ug/ml)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Albumin ExcretionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, suzy abdelaziz Abdelhamid, Kasr El Aini Hospital
- Investigators
- suzy abdelaziz, M.D., Principal investigator, kasrelaini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569164
- Sponsor's protocol ID
- kasrelaini Obgyn..
- Status last verified
- Oct 2015
- First submitted
- 26 Aug 2015
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Albumin Excretion in Women With Polycyclic Ovary Syndrome and it's Relation to Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT02569164
- Acronym / sponsor ID
- kasrelaini Obgyn..
- Conditions
- Urinary Albumin Excretion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- PCO patients
Key inclusion criteria (1 listed)
- PCO patients
Key exclusion criteria (5 listed)
- pregnancy
- diabetes
- hypertension
- adrenal dysfunction
- thyroid dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with hyperinsulinemia (uIU/ml)
Time frame: 3 months
Number of patients with hyperlipidemia (mg/dl).
Time frame: 3 months
Number of patients with albuminuria(ug/ml)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
suzy abdelaziz, M.D. principal investigator
kasrelaini
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Albumin Excretion, run by Kasr El Aini Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact suzy abdelaziz, M.D. (01003726195, suzyabdelaziz92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with hyperinsulinemia (uIU/ml) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.