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

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra (Other)

Overall Status

Unknown status

CT.gov ID

NCT01055626

Collaborator

(none)

6,000

Enrollment

Locations

155

Duration (Months)

3000

Patients Per Site

19.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight Diabetes Mellitus, Type 2

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

6000 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Jan 1, 2005

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2017

Outcome Measures

Primary Outcome Measures

Differences in body fat [Baseline]
For classically defined BMI categories (normalweight, overweight and obesity) body fat will be assessed by air-displacement plethysmography (Bod-Pod)

Secondary Outcome Measures

Differences in glycemic control [Baseline]
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.
Differences in cardiovascular risk factors [Baseline]
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.