Women With Polycystic Ovary Syndrome (PCOS) (PCOS)

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

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

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Carolina F Macruz, doctor; Phone Number: Brazil +5511999141447; Email: carolmacruz@gmail.com
• Study Contact Backup: Name: Irmandade Santa Casa Sao Paulo; Phone Number: Brazil +551121767385

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01225001
    • Recruiting
    • Carolina Furtado Macruz
    • Contact: Carolina Macruz; Phone Number: +5511999141447; Email: carolmacruz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 39 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic profile	total cholesterol (mg/dL) and fractions, triglycerides (mg/dL) will estimate	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo
• Investigators: Principal Investigator: Carolina Macruz, Irmandade Santa Casa de Misericordia Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: June 7, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Actual): March 20, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: 167/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: When I have finished my recruitment and analysis of the results.