Women With Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome Clinical Trial

— PCOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02467751
• Other study ID #: 167/10
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2015
• Last updated: March 17, 2017
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Irmandade da Santa Casa de Misericordia de Sao Paulo
• Contact: Carolina F Macruz, doctor
• Phone: +5511999141447
• Email: carolmacruz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
Brazil	Carolina Furtado Macruz	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Irmandade da Santa Casa de Misericordia de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic profile	total cholesterol (mg/dL) and fractions, triglycerides (mg/dL) will estimate	12 months
Secondary	Classical glycemic index	Classical glycemic index (mg/dL) will estimate	12 months
Secondary	Liver function	Liver function (U/L) will estimate	12 months
Secondary	luteinizing hormone	luteinizing hormone (IU/L) will estimate	12 months
Secondary	Hormonal profile - insulin	Hormonal profile - insulin (uIU/ml) will estimate	12 months
Secondary	Follicle stimulating hormone	Follicle stimulating hormone (IU/L) will estimate	12 months
Secondary	thyreostimulating hormone	thyreostimulating hormone (uIU/ML) will estimate	12 months
Secondary	Total and free testosterone	Total and free testosterone (ng/ml) will estimate	12 months
Secondary	17-hydroxyprogesterone	17-hydroxyprogesterone (ng/ml) will estimate	12 months
Secondary	Dehydroepiandrosterone	Dehydroepiandrosterone (ng/ml) will estimate	12 months
Secondary	Prolactin	Prolactin (ug/ml) will estimate	12 months
Secondary	DEXA	Body composition will measure by DEXA scan	12 months