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临床试验/NCT03410316
NCT03410316
进行中(未招募)
不适用

The Netherlands Epidemiology of Obesity Study

Leiden University Medical Center0 个研究点目标入组 6,671 人2008年8月4日
适应症Obesity

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Obesity
发起方
Leiden University Medical Center
入组人数
6671
主要终点
Incidence of common diseases
状态
进行中(未招募)
最后更新
7年前

概览

简要总结

The Netherlands Epidemiology of Obesity (NEO) study is a population-based cohort study in 6671 men and women aged 45 to 65 years, with an oversampling of individuals with a BMI of 27 kg/m2 or higher. The NEO study is designed to investigate pathways that lead to common diseases and conditions.

Men and women aged between 45 and 65 years with a self-reported BMI of 27 kg/m2 or higher living in the greater area of Leiden, the Netherlands, were eligible to participate in the NEO study. Participants were recruited via three recruitment strategies. First, participants were recruited by general practitioners in the area of Leiden, in the West of The Netherlands. Second, participants were recruited through advertisements in local newspapers and through posters distributed in public areas of Leiden and surroundings. Third, participants were recruited via the registries of three municipalities surrounding Leiden (Katwijk, Leiderdorp and Teylingen). Inhabitants of Katwijk and Teylingen aged between 45 and 65 years were invited to participate if they had a self-reported BMI of 27 kg/m2 or higher. All inhabitants aged between 45 and 65 years of Leiderdorp were invited to participate irrespective of their BMI, allowing for a reference distribution of BMI.

Participants were invited to a baseline visit at NEO study centre of the LUMC after an overnight fast. Prior to this study visit, participants collected their urine over 24 h and completed a general questionnaire at home to report demographic, lifestyle and clinical information. The participants were asked to bring all medication they were using to the study visit. At the baseline visit an extensive physical examination was performed, including measurements of anthropometry, blood pressure, both fasting and postprandial blood sampling (30 minutes and 2.5 hours after a liquid mixed meal), ECG, carotid artery IMT, and pulmonary function tests. In random subsets of participants MRI of abdominal fat, brain, knee, heart function, and pulse wave velocity of the aorta was performed, as well as indirect calorimetry, accelerometry combined with continuous heart rate, and total sleep time with actigraphy. Participants are followed via their general practitioners and hospital registries for the incidence of common diseases and mortality.

详细描述

Hypotheses 1. Overweight and obesity affect major systemic responses, such as inflammation and coagulation that lead to the occurrence of major common diseases. 2. The occurrence of these diseases is related to individual make-up, including genetics and fat type and location, and environment, and the interaction between the various systemic responses, and the (subclinical) disease outcomes. Primary general objectives of the NEO study 1. To study the pathways that lead to common diseases in overweight and obese individuals. 2. To identify novel determinants of various diseases and conditions in overweight and obese individuals. 3. To study interrelationships between diseases, newly identified determinants with each other and with classical, established risk factors. Secondary general objectives of the NEO Study 1. To identify novel determinants of various subclinical conditions in overweight and obese individuals. 2. To develop novel methods for determining the risk of various diseases and conditions in asymptomatic overweight and obese individuals, in addition to established prognostic markers. 3. To assess the burden of disease in a population-based cohort of overweight and obese individuals. 4. To investigate the optimal diagnostic method to define overweight and obesity in terms of predicting various diseases.

注册库
clinicaltrials.gov
开始日期
2008年8月4日
结束日期
2033年9月
最后更新
7年前
研究类型
Observational
性别
All

研究者

发起方
Leiden University Medical Center
责任方
Principal Investigator
主要研究者

FritsRRosendaal

MD PhD

Leiden University Medical Center

入排标准

入选标准

  • Men and women
  • Aged 45 to 65
  • Self-reported BMI of 27kg/m2 or higher
  • Subgroup of participants irrespective of their BMI

排除标准

  • 未提供

结局指标

主要结局

Incidence of common diseases

时间窗: Around each 5 years

e.g. type 2 diabetes (yes/no), cardiovascular diseases (y/n), thrombosis (y/n), chronic kidney disease (y/n), asthma (y/n), chronic obstructive pulmonary disease (y/n), osteoarthritis (y/n), cirrhosis (y/n), depression (y/n)

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