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Women With Polycystic Ovary Syndrome (PCOS)

Metabolic Profile in Women of Different Body Composition With Polycystic Ovary Syndrome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02467751
Acronym
PCOS
Enrollment
90
Registered
2015-06-10
Start date
2014-01-31
Completion date
2017-12-31
Last updated
2017-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Brief summary

Metabolic profile in women of different body composition with polycystic ovary syndrome.

Detailed description

Will be performed case-control study with women with Polycystic Ovary Syndrome, according to the Rotterdam criteria and body mass index between 18 to 29.9. The control group will consist of women without Polycystic Ovary Syndrome, with a body mass index of 18 to 29.9 and no other comorbidities. In both groups collect anthropometric data such as age, weight, height, waist circumference and blood pressure. Exams will be requested: metabolic profile (total cholesterol (mg/dL) and fractions, triglycerides (mg/dL), blood count, liver function (U/L) and classical glycemic index (mg/dL); hormonal profile - insulin (uIU/ml), luteinizing hormone (IU/L), follicle stimulating hormone (IU/L), thyreostimulating hormone (uIU/ML), total and free testosterone (ng/ml), 17-hydroxyprogesterone (ng/ml), dehydroepiandrosterone (ng/ml), prolactin (ug/ml). Body composition (BMI) will be performed by absorption technique of two low energy beams emitted by X-ray - full body densitometry (DEXA). Expected result: To evaluate visceral fat and truncal of patients with diagnosis of Polycystic Ovary Syndrome without obesity.

Interventions

None listed

Sponsors

Irmandade da Santa Casa de Misericordia de Sao Paulo
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 39 Years
Healthy volunteers
Yes

Inclusion criteria

* Polycystic Ovary Syndrome , body mass index of 18 to 29.9, without contraceptive use.

Exclusion criteria

* Hypothyroidism, hyperprolactinaemia (defined as serum prolactin levels greater than 25 ng/mL) * Cushing's syndrome * Nonclassical congenital adrenal hyperplasia (defined as serum 17-hydroxyprogesterone levels greater than 1.2 and 5.2 ng/mL in the follicular and luteal phase, respectively) and current or previous (within the last three months) use of oral contraceptives and other hormonal * Antidiabetic and antiobesity drugs.

Design outcomes

Primary

MeasureTime frameDescription
Metabolic profile12 monthstotal cholesterol (mg/dL) and fractions, triglycerides (mg/dL) will estimate

Secondary

MeasureTime frameDescription
Liver function12 monthsLiver function (U/L) will estimate
luteinizing hormone12 monthsluteinizing hormone (IU/L) will estimate
Hormonal profile - insulin12 monthsHormonal profile - insulin (uIU/ml) will estimate
Follicle stimulating hormone12 monthsFollicle stimulating hormone (IU/L) will estimate
thyreostimulating hormone12 monthsthyreostimulating hormone (uIU/ML) will estimate
Classical glycemic index12 monthsClassical glycemic index (mg/dL) will estimate
17-hydroxyprogesterone12 months17-hydroxyprogesterone (ng/ml) will estimate
Dehydroepiandrosterone12 monthsDehydroepiandrosterone (ng/ml) will estimate
Prolactin12 monthsProlactin (ug/ml) will estimate
DEXA12 monthsBody composition will measure by DEXA scan
Total and free testosterone12 monthsTotal and free testosterone (ng/ml) will estimate

Countries

Brazil

Contacts

Primary ContactCarolina F Macruz, doctor
carolmacruz@gmail.com+5511999141447
Backup ContactIrmandade Santa Casa Sao Paulo
+551121767385

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026