New Body Mass Index (BMI) Cut-offs for the Diagnosis of Obesity and Comorbidities
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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 |
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) |
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 |
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 .
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| Contact: Gema Frühbeck, MD, PhD | 34 948255400 ext 4484 | gfruhbeck@unav.es |
| 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 | |
| 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 May 23, 2013