Polycystic Ovary SyndromeNCT02435888
Predictive Equations for Resting Energy Expenditure
An observational study of Polycystic Ovary Syndrome, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Predictive equations are the main clinical tool for determining resting energy expenditure (REE). Thus, it is important to investigate the accuracy and agreement of these equations in different populations and context of diseases. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2012to Jun 2013
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Polycystic ovary syndrome patients, as defined according to the Rotterdam criteria (ESHRE/ASMR, 2004): the presence of at least two of the following factors: chronic anovulation, clinical or biochemical signs of hyperandrogenism and presence of polycystic ovaries;
Who may be able to join
- Women treated in an endocrinology centre specialising in hyperandrogenism at the university hospital of University Federal of Minas Gerais (Belo Horizonte, Minas Gerais, Brazil)
- The patients were of reproductive age (range: 18-45 years)
- were overweight or obese (Body mass index ≥ 25.0 kg/m2) and
- signed an informed consent statement
Who cannot join
- Women who were pregnant,
- were lactating,
- had a diagnosis of hypothyroidism or hyperthyroidism or
- had high physical activity levels were excluded from the sample.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy and Agreement of Predictive Equations for Resting Energy Expenditure Among Overweight Patients With Polycystic Ovary Syndrome
Predictive equations are the main clinical tool for determining resting energy expenditure (REE). Thus, it is important to investigate the accuracy and agreement of these equations in different populations and context of diseases. The purpose of this study is to investigate the accuracy and agreement of predictive equations of REE in overweight women with polycystic ovary syndrome (PCOS). The REE of all participants was measured (mREE) by means of indirect calorimetry and predicted (pREE) through ten equations basing on the anthropometric parameters (Harris \& Benedict, WHO/FAO/UNU including weight, WHO/FAO/UNU including weight and height, Owen, Mifflin-St. Jeor, Institute of Medicine, Ireton-Jones, Müeller, De Luis and Lazzer).
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Resting energy expenditure, Predictive equations, Overweight
- Medical subject headings
- Polycystic Ovary Syndrome, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Polycystic ovary syndrome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and agreement of predictive equations of resting energy expenditure
Measured: Six month
Secondary outcomes (1)
Comparison and correlation between the resting energy expenditure measured by means of indirect calorimetry and predicted through equations.
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionJun 2013
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.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
- Investigators
- Adaliene VM Ferreira, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435888
- Sponsor's protocol ID
- ETIC 0244.0.0203.000-10
- Status last verified
- May 2015
- First submitted
- 3 May 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodrigues AMDS, Costa ABP, Campos DL, Silva MPS, Candido AL, Santos LCD, Ferreira AVM. Low validity of predictive equations for calculating resting energy expenditure in overweight and obese women with polycystic ovary syndrome. J Hum Nutr Diet. 2018 Apr;31(2):266-275. doi: 10.1111/jhn.12498. Epub 2017 Aug 8.
PubMed 28791776
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Agreement of Predictive Equations for Resting Energy Expenditure Among Overweight Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT02435888
- Acronym / sponsor ID
- ETIC 0244.0.0203.000-10
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Resting energy expenditure, Predictive equations, Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 May 2015 (estimated)
- 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.
Predictive equations are the main clinical tool for determining resting energy expenditure (REE). Thus, it is important to investigate the accuracy and agreement of these equations in different populations and context of diseases. The purpose of this study is to investigate the accuracy and agreement of predictive equations of REE in overweight women with polycystic ovary syndrome (PCOS). The REE of all participants was measured (mREE) by means of indirect calorimetry and predicted (pREE) through ten equations basing on the anthropometric parameters (Harris \& Benedict, WHO/FAO/UNU including weight, WHO/FAO/UNU including weight and height, Owen, Mifflin-St. Jeor, Institute of Medicine, Ireton-Jones, Müeller, De Luis and Lazzer).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polycystic ovary syndrome | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Polycystic ovary syndrome patients, as defined according to the Rotterdam criteria (ESHRE/ASMR, 2004): the presence of at least two of the following factors: chronic anovulation, clinical or biochemical signs of hyperandrogenism and presence of polycystic ovaries;
Key inclusion criteria (4 listed)
- Women treated in an endocrinology centre specialising in hyperandrogenism at the university hospital of University Federal of Minas Gerais (Belo Horizonte, Minas Gerais, Brazil)
- The patients were of reproductive age (range: 18-45 years)
- were overweight or obese (Body mass index ≥ 25.0 kg/m2) and
- signed an informed consent statement
Key exclusion criteria (4 listed)
- Women who were pregnant,
- were lactating,
- had a diagnosis of hypothyroidism or hyperthyroidism or
- had high physical activity levels were excluded from the sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy and agreement of predictive equations of resting energy expenditure
Time frame: Six month
1 secondary outcome
Comparison and correlation between the resting energy expenditure measured by means of indirect calorimetry and predicted through equations.
Time frame: Six month
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 6 May 2015.
- Derived from this study: PubMed 28791776Rodrigues AMDS, Costa ABP, Campos DL, Silva MPS, Candido AL, Santos LCD, Ferreira AVM. Low validity of predictive equations for calculating resting energy expenditure in overweight and obese women with polycystic ovary syndrome. J Hum Nutr Diet. 2018 Apr;31(2):266-275. doi: 10.1111/jhn.12498. Epub 2017 Aug 8.
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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.
Adaliene VM Ferreira, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Federal University of Minas Gerais at 1 site in Brazil.
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 4 inclusion and 4 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 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Accuracy and agreement of predictive equations of resting energy expenditure (time frame: Six month). 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 NCT02435888, 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 6 May 2015.