NCT03132545

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

3.9 years

First QC Date

April 24, 2017

Last Update Submit

April 24, 2017

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • differences in resting metabolic rate

    2 days

Secondary Outcomes (1)

  • differences in body fat distribution

    1 day

Study Arms (2)

PCOS

Diagnostic Test: SenseWear Armband (SWA) monitoringDiagnostic Test: total body dual-energy X-ray absorptiometry

controls

Diagnostic Test: SenseWear Armband (SWA) monitoringDiagnostic Test: total body dual-energy X-ray absorptiometry

Interventions

SenseWear Armband (SWA) monitoringDIAGNOSTIC_TEST

Participants wore the SWA on their right arm

PCOScontrols
total body dual-energy X-ray absorptiometryDIAGNOSTIC_TEST

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

PCOScontrols

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

group 1: women with PCOS diagnosed according with the Rotterdam Consensus Conference criteria group 2: healty women

You may qualify if:

  • PCOS diagnosed according with the Rotterdam Consensus Conference criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30847861DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 24, 2017

First Posted

April 28, 2017

Study Start

January 1, 2013

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

April 28, 2017

Record last verified: 2017-04