Women With Polycystic Ovary Syndrome (PCOS)
PCOS
Metabolic Profile in Women of Different Body Composition With Polycystic Ovary Syndrome
1 other identifier
observational
90
1 country
1
Brief Summary
Metabolic profile in women of different body composition with polycystic ovary syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 25, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 20, 2017
March 1, 2017
3.7 years
March 25, 2015
March 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Metabolic profile
total cholesterol (mg/dL) and fractions, triglycerides (mg/dL) will estimate
12 months
Secondary Outcomes (11)
Classical glycemic index
12 months
Liver function
12 months
luteinizing hormone
12 months
Hormonal profile - insulin
12 months
Follicle stimulating hormone
12 months
- +6 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- Polycystic Ovary Syndrome , body mass index of 18 to 29.9, without contraceptive use.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carolina Furtado Macruz
São Paulo, São Paulo, 01225001, Brazil
Related Publications (2)
Macruz CF, Lima SMRR. Polycystic ovary syndrome and abdominal fat: is there a relationship? Rev Assoc Med Bras (1992). 2023 Oct 27;69(11):e20230874. doi: 10.1590/1806-9282.20230874. eCollection 2023.
PMID: 37909624DERIVEDMacruz 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.
PMID: 28099715DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carolina Macruz
Irmandade Santa Casa de Misericordia Sao Paulo
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
March 25, 2015
First Posted
June 10, 2015
Study Start
January 1, 2014
Primary Completion
September 1, 2017
Study Completion
December 1, 2017
Last Updated
March 20, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share
When I have finished my recruitment and analysis of the results.