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

NCT01055626 | Unknown

• 1 other identifier: OBECUN-BF-01
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Differences in body fat

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

  Baseline

Secondary Outcomes (2)

• Differences in glycemic control

  Baseline

• Differences in cardiovascular risk factors

  Baseline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• BMI \>18.5
• No major organ disease unrelated to excess body weight

You may not qualify if:

• Pregnancy/lactation
• History of eating disorder or major psychiatric illness

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (2)

Clinica Universidad de Navarra - University of Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, Spain

ENROLLING BY INVITATION

Related Publications (4)

• 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.

  PMID: 21394093 RESULT

• 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.

  PMID: 21587201 RESULT

• 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.

  PMID: 28187933 DERIVED

• 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.

  PMID: 22179957 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gema Frühbeck, MD, PhD

  Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gema Frühbeck, MD, PhD

CONTACT

34 948255400; gfruhbeck@unav.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD.

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 25, 2010
• Study Start: January 1, 2005
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: October 26, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)