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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SenseWear Armband (SWA) monitoring

Diagnostic Test

Participants wore the SWA on their right arm

Total Body Dual-energy X-ray Absorptiometry

Diagnostic Test

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

Primary outcomes

differences in resting metabolic rate

Time frame: 2 days

Secondary outcomes

differences in body fat distribution

Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2017
First posted: Apr 28, 2017
Registry last updated: Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed