Clinical trial NCT02435888: Predictive Equations for Resting Energy Expenditure
Official title: Accuracy and Agreement of Predictive Equations for Resting Energy Expenditure Among Overweight Patients With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: Resting energy expenditure
Predictive equations
Overweight
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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;

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Women who were pregnant,
* were lactating,
* had a diagnosis of hypothyroidism or hyperthyroidism or
* had high physical activity levels were excluded from the sample.

Primary outcomes:
measure: Accuracy and agreement of predictive equations of resting energy expenditure
timeFrame: Six month
Secondary outcomes:
measure: Comparison and correlation between the resting energy expenditure measured by means of indirect calorimetry and predicted through equations.
timeFrame: Six month
Other outcomes:
Locations:
city: Belo horizonte
country: Brazil
facility: UFMG Hospital
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Adaliene VM Ferreira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.