New Body Mass Index (BMI) Cut-offs for the Diagnosis of Obesity and Comorbidities

Obesity Clinical Trial

Official title:

Usefulness of the Determination of Body Composition for Establishing New Cut-offs for the Diagnosis and Follow-up of Obesity and Comorbidities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01055626
• Other study ID #: OBECUN-BF-01
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2010
• Last updated: October 24, 2016
• Start date: January 2005
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: Gema Frühbeck, MD, PhD
• Phone: 34 948255400
• Email: gfruhbeck[@]unav.es
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Obesity is a serious medical problem because it increases the risk of cardiovascular disease (CVD), type 2 diabetes mellitus, and certain forms of cancer. The definition of obesity is based on an excess of body fat, not of BMI. However, BMI is the reference used to establish a graded classification of weight relative to height. Although BMI is widely used as a simple surrogate measure of body fat and has been shown to correlate closely with adiposity, it would be more appropriate to determine body fat percentage and to use this value for classification purposes. The present study contemplates the determination of the per cent body fat with the aim of establishing new diagnostic and therapeutic criteria according to the associated comorbidities.

Description:

The prevalence of overweight and obesity has increased alarmingly in the last decades. Obesity is a serious medical problem because it increases the risk of hypertension, type 2 diabetes mellitus, coronary heart disease, sleep-breathing disorders, and certain forms of cancer. Obesity is defined medically as a state of increased adipose tissue of sufficient magnitude to produce adverse health consequences. The definition of obesity is based on an excess of body fat, not of BMI. However, BMI is the reference used to establish a graded classification of weight relative to height. Although BMI is widely used as a simple surrogate measure of body fat and has been shown to correlate closely with adiposity, it would be more appropriate to determine body fat percentage and to use this value for classification purposes. The present study contemplates the determination of the per cent body fat (by air displacement plethysmography) in more than 5,000 subjects representing the whole BMI range, with the aim of establishing new diagnostic and therapeutic criteria according to the associated comorbidities. The specific objectives are: a) To know the body fat percentage means for normal weight, overweight and obesity for both sexes. b) To know the body fat percentage means for normal weight, overweight and obesity for the different age ranges. c) To analyse the relationship between body fat percentage and BMI values in order to detect misclassified individuals. d) To establish new cut-offs for body fat percentage and the normality ranges according to its relationship with cardiovascular risk factors that could be useful in the diagnosis and therapy of obesity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• BMI >18.5

• No major organ disease unrelated to excess body weight

Exclusion Criteria:

• Pregnancy/lactation

• History of eating disorder or major psychiatric illness

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight

Locations

Country	Name	City	State
Spain	Clinica Universidad de Navarra	Pamplona
Spain	Clinica Universidad de Navarra - University of Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Gómez-Ambrosi J, Silva C, Galofré JC, Escalada J, Santos S, Gil MJ, Valentí V, Rotellar F, Ramírez B, Salvador J, Frühbeck G. Body adiposity and type 2 diabetes: increased risk with a high body fat percentage even having a normal BMI. Obesity (Silver Spri — View Citation

Gómez-Ambrosi J, Silva C, Galofré JC, Escalada J, Santos S, Millán D, Vila N, Ibañez P, Gil MJ, Valentí V, Rotellar F, Ramírez B, Salvador J, Frühbeck G. Body mass index classification misses subjects with increased cardiometabolic risk factors related to — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in body fat	For classically defined BMI categories (normalweight, overweight and obesity) body fat will be assessed by air-displacement plethysmography (Bod-Pod)	Baseline	No
Secondary	Differences in glycemic control	For classically-defined BMI categories measurement of fasting plasma glucose, insulin HOMA as well as response to OGTT will be related to actual body adiposity.	Baseline	No
Secondary	Differences in cardiovascular risk factors	For classically-defined BMI categories measurement of circulating total cholesterol, LDL-cholesterol, HDL-cholesterol, fibrinogen, C-reactive protein, homocysteine, von Willebrand factor and adipokines will be related to actual body adiposity.	Baseline	No