Polycystic Ovary SyndromeNCT03132545
Resting Metabolic Rate, Fat Distribution, Endocrine and Metabolic Features in Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- SenseWear Armband (SWA) monitoring and total body dual-energy X-ray absorptiometry
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: group 1: women with PCOS diagnosed according with the Rotterdam Consensus Conference criteria group 2: healty women
Who may be able to join
- . PCOS diagnosed according with the Rotterdam Consensus Conference criteria
Who cannot join
- presence of a late-onset adrenal enzyme defect
- Significant liver or renal impairment
- pregnancy and nursing
- neoplasm
- cardiovascular disease
- other hormonal dysfunctions
About this study
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
- Polycystic Ovary Syndrome
- Being tested
- SenseWear Armband (SWA) monitoring, total body dual-energy X-ray absorptiometry
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenseWear Armband (SWA) monitoringDiagnostic test
Participants wore the SWA on their right arm
total body dual-energy X-ray absorptiometryDiagnostic test
DEXA was used to estimate abdominal visceral adipose tissue and subcutaneous adipose tissue
| Study group | Role | What they receive |
|---|---|---|
| PCOS | Not described Receives: Diagnostic Test: SenseWear Armband (SWA) monitoring; Diagnostic Test: total body dual-energy X-ray absorptiometry | |
| controls | Not described Receives: Diagnostic Test: SenseWear Armband (SWA) monitoring; Diagnostic Test: total body dual-energy X-ray absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in resting metabolic rate
Measured: 2 days
Secondary outcomes (1)
differences in body fat distribution
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study startJan 2013
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeria Tagliaferri, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132545
- Sponsor's protocol ID
- ARMOC
- Status last verified
- Apr 2017
- First submitted
- 24 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30847861
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Metabolic Rate, Fat Distribution, Endocrine and Metabolic Features in Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03132545
- Acronym / sponsor ID
- ARMOC
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS | – | Diagnostic Test: SenseWear Armband (SWA) monitoring, Diagnostic Test: total body dual-energy X-ray absorptiometry |
| controls | – | Diagnostic Test: SenseWear Armband (SWA) monitoring, Diagnostic Test: total body dual-energy X-ray absorptiometry |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- group 1: women with PCOS diagnosed according with the Rotterdam Consensus Conference criteria group 2: healty women
Key inclusion criteria (1 listed)
- . PCOS diagnosed according with the Rotterdam Consensus Conference criteria
Key exclusion criteria (6 listed)
- presence of a late-onset adrenal enzyme defect
- Significant liver or renal impairment
- pregnancy and nursing
- neoplasm
- cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SenseWear Armband (SWA) monitoringParticipants wore the SWA on their right arm | Diagnostic test | PCOS, controls |
| total body dual-energy X-ray absorptiometryDEXA was used to estimate abdominal visceral adipose tissue and subcutaneous adipose tissue | Diagnostic test | PCOS, controls |
Primary outcome
differences in resting metabolic rate
Time frame: 2 days
1 secondary outcome
differences in body fat distribution
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Derived from this study: PubMed 30847861Romualdi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in resting metabolic rate (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03132545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.