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Trial record 34 of 566 for:    "Polycystic Ovary Syndrome"

Women With Polycystic Ovary Syndrome (PCOS) (PCOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02467751
Recruitment Status : Unknown
Verified March 2017 by Carolina Furtado Macruz, Irmandade da Santa Casa de Misericordia de Sao Paulo.
Recruitment status was:  Recruiting
First Posted : June 10, 2015
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Carolina Furtado Macruz, Irmandade da Santa Casa de Misericordia de Sao Paulo

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

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Metabolic Profile in Women of Different Body Composition With Polycystic Ovary Syndrome
Study Start Date : January 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Metabolic profile [ Time Frame: 12 months ]
    total cholesterol (mg/dL) and fractions, triglycerides (mg/dL) will estimate


Secondary Outcome Measures :
  1. Classical glycemic index [ Time Frame: 12 months ]
    Classical glycemic index (mg/dL) will estimate

  2. Liver function [ Time Frame: 12 months ]
    Liver function (U/L) will estimate

  3. luteinizing hormone [ Time Frame: 12 months ]
    luteinizing hormone (IU/L) will estimate

  4. Hormonal profile - insulin [ Time Frame: 12 months ]
    Hormonal profile - insulin (uIU/ml) will estimate

  5. Follicle stimulating hormone [ Time Frame: 12 months ]
    Follicle stimulating hormone (IU/L) will estimate

  6. thyreostimulating hormone [ Time Frame: 12 months ]
    thyreostimulating hormone (uIU/ML) will estimate

  7. Total and free testosterone [ Time Frame: 12 months ]
    Total and free testosterone (ng/ml) will estimate

  8. 17-hydroxyprogesterone [ Time Frame: 12 months ]
    17-hydroxyprogesterone (ng/ml) will estimate

  9. Dehydroepiandrosterone [ Time Frame: 12 months ]
    Dehydroepiandrosterone (ng/ml) will estimate

  10. Prolactin [ Time Frame: 12 months ]
    Prolactin (ug/ml) will estimate

  11. DEXA [ Time Frame: 12 months ]
    Body composition will measure by DEXA scan



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467751


Contacts
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Contact: Carolina F Macruz, doctor +5511999141447 ext Brazil carolmacruz@gmail.com
Contact: Irmandade Santa Casa Sao Paulo +551121767385 ext Brazil

Locations
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Brazil
Carolina Furtado Macruz Recruiting
Sao Paulo, Brazil, 01225001
Contact: Carolina Macruz    +5511999141447    carolmacruz@gmail.com   
Sponsors and Collaborators
Irmandade da Santa Casa de Misericordia de Sao Paulo
Investigators
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Principal Investigator: Carolina Macruz Irmandade Santa Casa de Misericordia Sao Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carolina Furtado Macruz, Doctor, Irmandade da Santa Casa de Misericordia de Sao Paulo
ClinicalTrials.gov Identifier: NCT02467751     History of Changes
Other Study ID Numbers: 167/10
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: When I have finished my recruitment and analysis of the results.

Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases