Clinical trial · Observational
Resting Metabolic Rate, Fat Distribution, Endocrine and Metabolic Features in Polycystic Ovary Syndrome
NCT03132545CI-TRIAL-00027253completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SenseWear Armband (SWA) monitoring | Diagnostic Test | — | UNRESOLVED |
| total body dual-energy X-ray absorptiometry | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PCOS
- interventionNames
- Diagnostic Test: SenseWear Armband (SWA) monitoring
- Diagnostic Test: total body dual-energy X-ray absorptiometry
- label
- controls
- interventionNames
- Diagnostic Test: SenseWear Armband (SWA) monitoring
- Diagnostic Test: total body dual-energy X-ray absorptiometry
Primary outcomes (1)
- measure
- differences in resting metabolic rate
- timeFrame
- 2 days
Secondary outcomes (1)
- measure
- differences in body fat distribution
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRomualdi 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. PMID 30847861