Predictive Equations for Resting Energy Expenditure

Polycystic Ovary Syndrome Clinical Trial

Official title:

Accuracy and Agreement of Predictive Equations for Resting Energy Expenditure Among Overweight Patients With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435888
• Other study ID #: ETIC 0244.0.0203.000-10
• Status: Completed
• Phase: N/A
• First received: May 3, 2015
• Last updated: May 5, 2015
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: May 2015
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Locations

Country	Name	City	State
Brazil	UFMG Hospital	Belo horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy and agreement of predictive equations of resting energy expenditure		Six month	No
Secondary	Comparison and correlation between the resting energy expenditure measured by means of indirect calorimetry and predicted through equations.		Six month	No