Clinical trial NCT02467751: Women With Polycystic Ovary Syndrome (PCOS)
Official title: Metabolic Profile in Women of Different Body Composition With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metabolic profile
timeFrame: 12 months
Secondary outcomes:
measure: Classical glycemic index
timeFrame: 12 months
measure: Liver function
timeFrame: 12 months
measure: luteinizing hormone
timeFrame: 12 months
measure: Hormonal profile - insulin
timeFrame: 12 months
measure: Follicle stimulating hormone
timeFrame: 12 months
measure: thyreostimulating hormone
timeFrame: 12 months
measure: Total and free testosterone
timeFrame: 12 months
measure: 17-hydroxyprogesterone
timeFrame: 12 months
measure: Dehydroepiandrosterone
timeFrame: 12 months
measure: Prolactin
timeFrame: 12 months
measure: DEXA
timeFrame: 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Carolina Furtado Macruz
Study officials:
affiliation: Irmandade Santa Casa de Misericordia Sao Paulo
name: Carolina Macruz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Macruz CF, Lima SM, Salles JE, da Silva GM, Scalissi NM. Assessment of the body composition of patients with polycystic ovary syndrome using dual-energy X-ray absorptiometry. Int J Gynaecol Obstet. 2017 Mar;136(3):285-289. doi: 10.1002/ijgo.12066. Epub 2017 Jan 6.