Obesity Clinical Trial
Official title:
The Netherlands Epidemiology of Obesity Study
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.
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.
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