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

NCT ID: NCT01055626

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Overweight Diabetes Mellitus, Type 2

Keywords

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Body mass index Body fat Obesity Overweight Diabetes Mellitus, Type 2 Air displacement plethysmography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

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Gema Frühbeck Martínez

MD, PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gema Frühbeck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clínica Universidad de Navarra

Locations

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Clinica Universidad de Navarra - University of Navarra

Pamplona, Navarre, Spain

Site Status RECRUITING

Clinica Universidad de Navarra

Pamplona, , Spain

Site Status ENROLLING_BY_INVITATION

Countries

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Spain

Central Contacts

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Gema Frühbeck, MD, PhD

Role: CONTACT

Phone: 34 948255400

Email: [email protected]

Facility Contacts

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Gema Frühbeck, MD, PhD

Role: primary

References

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Gomez-Ambrosi J, Silva C, Galofre JC, Escalada J, Santos S, Gil MJ, Valenti V, Rotellar F, Ramirez B, Salvador J, Fruhbeck G. Body adiposity and type 2 diabetes: increased risk with a high body fat percentage even having a normal BMI. Obesity (Silver Spring). 2011 Jul;19(7):1439-44. doi: 10.1038/oby.2011.36. Epub 2011 Mar 10.

Reference Type RESULT
PMID: 21394093 (View on PubMed)

Gomez-Ambrosi J, Silva C, Galofre JC, Escalada J, Santos S, Millan D, Vila N, Ibanez P, Gil MJ, Valenti V, Rotellar F, Ramirez B, Salvador J, Fruhbeck G. Body mass index classification misses subjects with increased cardiometabolic risk factors related to elevated adiposity. Int J Obes (Lond). 2012 Feb;36(2):286-94. doi: 10.1038/ijo.2011.100. Epub 2011 May 17.

Reference Type RESULT
PMID: 21587201 (View on PubMed)

Gomez-Ambrosi J, Gonzalez-Crespo I, Catalan V, Rodriguez A, Moncada R, Valenti V, Romero S, Ramirez B, Silva C, Gil MJ, Salvador J, Benito A, Colina I, Fruhbeck G. Clinical usefulness of abdominal bioimpedance (ViScan) in the determination of visceral fat and its application in the diagnosis and management of obesity and its comorbidities. Clin Nutr. 2018 Apr;37(2):580-589. doi: 10.1016/j.clnu.2017.01.010. Epub 2017 Jan 28.

Reference Type DERIVED
PMID: 28187933 (View on PubMed)

Gomez-Ambrosi J, Silva C, Catalan V, Rodriguez A, Galofre JC, Escalada J, Valenti V, Rotellar F, Romero S, Ramirez B, Salvador J, Fruhbeck G. Clinical usefulness of a new equation for estimating body fat. Diabetes Care. 2012 Feb;35(2):383-8. doi: 10.2337/dc11-1334. Epub 2011 Dec 16.

Reference Type DERIVED
PMID: 22179957 (View on PubMed)

Other Identifiers

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OBECUN-BF-01

Identifier Type: -

Identifier Source: org_study_id