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Predictive Equations for Resting Energy Expenditure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435888
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais

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).

Condition or disease
Polycystic Ovary Syndrome

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Accuracy and Agreement of Predictive Equations for Resting Energy Expenditure Among Overweight Patients With Polycystic Ovary Syndrome
Study Start Date : December 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Polycystic ovary syndrome



Primary Outcome Measures :
  1. Accuracy and agreement of predictive equations of resting energy expenditure [ Time Frame: Six month ]

Secondary Outcome Measures :
  1. Comparison and correlation between the resting energy expenditure measured by means of indirect calorimetry and predicted through equations. [ Time Frame: Six month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435888


Locations
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Brazil
UFMG Hospital
Belo horizonte, Minas Gerais, Brazil, 30640100
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
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Principal Investigator: Adaliene VM Ferreira, PhD Federal University of Minas Gerais
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Isabel Toulson Davisson Correia, Professor, Department of Surgery, School of Medicine, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02435888    
Other Study ID Numbers: ETIC 0244.0.0203.000-10
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015
Keywords provided by Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais:
Resting energy expenditure
Predictive equations
Overweight
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases