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Resting Metabolic Rate, Fat Distribution, Endocrine and Metabolic Features in Polycystic Ovary Syndrome

NCT ID: NCT03132545

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-03-31

Brief Summary

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In a longitudinal, prospective and observational study, patients with PCOS and controls wore the SenseWear Armband for 2 days. Resting metabolic rati (kcal/die), total energy expenditure (MET, kcal) were evaluated. Ultrasonographic pelvic examinations, hirsutism score, anthropometric and menstrual pattern evaluation, hormonal profile assays, oral glucose tolerance test (OGTT) and lipid profile were performed.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PCOS

SenseWear Armband (SWA) monitoring

Intervention Type DIAGNOSTIC_TEST

Participants wore the SWA on their right arm

total body dual-energy X-ray absorptiometry

Intervention Type DIAGNOSTIC_TEST

DEXA was used to estimate abdominal visceral adipose tissue and subcutaneous adipose tissue

controls

SenseWear Armband (SWA) monitoring

Intervention Type DIAGNOSTIC_TEST

Participants wore the SWA on their right arm

total body dual-energy X-ray absorptiometry

Intervention Type DIAGNOSTIC_TEST

DEXA was used to estimate abdominal visceral adipose tissue and subcutaneous adipose tissue

Interventions

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SenseWear Armband (SWA) monitoring

Participants wore the SWA on their right arm

Intervention Type DIAGNOSTIC_TEST

total body dual-energy X-ray absorptiometry

DEXA was used to estimate abdominal visceral adipose tissue and subcutaneous adipose tissue

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* . PCOS diagnosed according with the Rotterdam Consensus Conference criteria

Exclusion Criteria

* presence of a late-onset adrenal enzyme defect
* Significant liver or renal impairment
* pregnancy and nursing
* neoplasm
* cardiovascular disease
* other hormonal dysfunctions
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Valeria Tagliaferri

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Romualdi D, Versace V, Tagliaferri V, De Cicco S, Immediata V, Apa R, Guido M, Lanzone A. The resting metabolic rate in women with polycystic ovary syndrome and its relation to the hormonal milieu, insulin metabolism, and body fat distribution: a cohort study. J Endocrinol Invest. 2019 Sep;42(9):1089-1097. doi: 10.1007/s40618-019-01029-2. Epub 2019 Mar 7.

Reference Type DERIVED
PMID: 30847861 (View on PubMed)

Other Identifiers

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ARMOC

Identifier Type: -

Identifier Source: org_study_id