Status:
UNKNOWN
Ovarian Hyperandrogenism in Normal and Excessive Body Weight Adolescent Girls and Their Relation to Diet (HAstudy)
Lead Sponsor:
Poznan University of Physical Education
Collaborating Sponsors:
National Science Centre, Poland
Poznan University of Medical Sciences
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
13-18 years
Phase:
NA
Brief Summary
The objective was 1. to check whether serum androgen levels and concomitant metabolic changes, oxidative stress and inflammation in adolescent girls with hyperandrogenism may be related to diet. 2. t...
Detailed Description
Hyperandrogenism in women is a state of increased androgen production, manifested by irregular menstrual cycles, a more frequent incidence of infertility, metabolic syndrome, oxidative stress, and inf...
Eligibility Criteria
Inclusion
- The criteria for the patient's inclusion were based on the 2003 Rotterdam criteria, with the presence of at least two of the following:
- written consent for inclusion (girls and their parents)
- clinical and/or biochemical hyperandrogenism (hirsutism with moderate to severe acne, and/or elevation of serum total testosterone or free testosterone,
- oligoovulation (based on oligomenorrhea defined as bleeding episodes occurring less than 8 times per year or secondary amenorrhea),
- polycystic ovarian picture in an ultrasound examination (at least 12 follicles in each ovary each measuring 2-9 mm in diameter and/or ovarian volume \>10 mL).
Exclusion
- any systemic disease, thyroid dysfunction, diabetes, congenital adrenal hyperplasia, Cushing syndrome, hyperprolactinemia suggestive of pituitary adenoma and androgen-secreting tumors
- medications of continuous use,
- the use of hormonal therapy or antibiotics in the past three months,
- vitamin or supplements use,
- alcohol consumption
- smoking
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04738409
Start Date
April 1 2018
End Date
December 31 2025
Last Update
December 8 2023
Active Locations (2)
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1
Poznan University of Medical Sciences
Poznan, Poland, 61-701
2
Poznan University of Physical Education
Poznan, Poland, 61-871