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

October 24, 2016 updated by: Gema Frühbeck Martínez, Clinica Universidad de Navarra, Universidad de Navarra

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gema Frühbeck, MD, PhD
  • Phone Number: 4484 34 948255400
  • Email: gfruhbeck@unav.es

Study Locations

  • Spain
      • Pamplona, Spain
        • Enrolling by invitation
        • Clinica Universidad de Navarra
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra - University of Navarra
        • Contact:
        • Sub-Investigator:
          • Javier Gómez-Ambrosi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Caucasian subjects able to come to Clinica Universidad de Navarra, Pamplona, Spain.

Patients visiting the Departments of Endocrinology and Surgery of the University Clinic of Navarra for weight loss treatment as well as hospital and University staff undergoing an annual routine health check-up .

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in body fat
Time Frame: Baseline
For classically defined BMI categories (normalweight, overweight and obesity) body fat will be assessed by air-displacement plethysmography (Bod-Pod)
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in glycemic control
Time Frame: 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.
Baseline
Differences in cardiovascular risk factors
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

  • Principal Investigator: Gema Frühbeck, MD, PhD, Clinica Universidad de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 22, 2010

First Submitted That Met QC Criteria

January 22, 2010

First Posted (Estimate)

January 25, 2010

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBECUN-BF-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe