Women With Polycystic Ovary Syndrome (PCOS)

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT02467751
• Lead Sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-06-07
• Study First Posted: 2015-06-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-03-20
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic profile	12 months	total cholesterol (mg/dL) and fractions, triglycerides (mg/dL) will estimate

Secondary Outcome Measures

Name	Time	Method
Classical glycemic index	12 months	Classical glycemic index (mg/dL) will estimate
Total and free testosterone	12 months	Total and free testosterone (ng/ml) will estimate
Follicle stimulating hormone	12 months	Follicle stimulating hormone (IU/L) will estimate
17-hydroxyprogesterone	12 months	17-hydroxyprogesterone (ng/ml) will estimate
Liver function	12 months	Liver function (U/L) will estimate
Hormonal profile - insulin	12 months	Hormonal profile - insulin (uIU/ml) will estimate
Prolactin	12 months	Prolactin (ug/ml) will estimate
luteinizing hormone	12 months	luteinizing hormone (IU/L) will estimate
thyreostimulating hormone	12 months	thyreostimulating hormone (uIU/ML) will estimate
Dehydroepiandrosterone	12 months	Dehydroepiandrosterone (ng/ml) will estimate
DEXA	12 months	Body composition will measure by DEXA scan

Trial Locations

Locations (1)

Carolina Furtado Macruz; 🇧🇷 Sao Paulo, Brazil