New Body Mass Index (BMI) Cut-offs for the Diagnosis of Obesity and Comorbidities
2016年10月24日 更新者: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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
6000
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Pamplona、西班牙
- 邀请报名
- Clinica Universidad de Navarra
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Navarra
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Pamplona、Navarra、西班牙、31008
- 招聘中
- Clinica Universidad de Navarra - University of Navarra
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接触:
- Gema Frühbeck, MD, PhD
- 电话号码:4484 34 948255400
- 邮箱:gfruhbeck@unav.es
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副研究员:
- Javier Gómez-Ambrosi, PhD
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
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 .
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:横截面
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Differences in body fat
大体时间:Baseline
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For classically defined BMI categories (normalweight, overweight and obesity) body fat will be assessed by air-displacement plethysmography (Bod-Pod)
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Baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Differences in glycemic control
大体时间: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
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Differences in cardiovascular risk factors
大体时间: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
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Gema Frühbeck, MD, PhD、Clinica Universidad de Navarra
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2005年1月1日
初级完成 (预期的)
2016年12月1日
研究完成 (预期的)
2017年12月1日
研究注册日期
首次提交
2010年1月22日
首先提交符合 QC 标准的
2010年1月22日
首次发布 (估计)
2010年1月25日
研究记录更新
最后更新发布 (估计)
2016年10月26日
上次提交的符合 QC 标准的更新
2016年10月24日
最后验证
2016年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.