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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Clinica Universidad de Navarra, Universidad de Navarra
Sponsor:
Information provided by (Responsible Party):
Gema Frühbeck Martínez, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01055626
First received: January 22, 2010
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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
Obesity
Overweight
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Biospecimen Retention:   Samples Without DNA

Serum and plasma


Estimated Enrollment: 6000
Study Start Date: January 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 .

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055626

Contacts
Contact: Gema Frühbeck, MD, PhD 34 948255400 ext 4484 gfruhbeck@unav.es

Locations
Spain
Clinica Universidad de Navarra - University of Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Gema Frühbeck, MD, PhD    34 948255400 ext 4484    gfruhbeck@unav.es   
Sub-Investigator: Javier Gómez-Ambrosi, PhD         
Clinica Universidad de Navarra Enrolling by invitation
Pamplona, Spain
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
Principal Investigator: Gema Frühbeck, MD, PhD Clínica Universidad de Navarra
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gema Frühbeck Martínez, MD, PhD., Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01055626     History of Changes
Other Study ID Numbers: OBECUN-BF-01
Study First Received: January 22, 2010
Last Updated: August 27, 2012
Health Authority: Spain: Ethics Committee
Spain: Ministry of Health

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Body mass index
Body fat
Obesity
Overweight
Diabetes Mellitus, Type 2
Air displacement plethysmography

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014