Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

The Netherlands Epidemiology of Obesity Study (NEO)

25 mars 2019 uppdaterad av: FritsRRosendaal, Leiden University Medical Center

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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

6671

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

45 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Men and women living in the greater area of Leiden (in the West of the Netherlands) were invited by letters sent by general practitioners, and via municipalities and by local advertisements.

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

  • NA

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Participants of the NEO study
Men and women aged 45 oy 65 years, with an oversampling of individuals with a BMI of 27 kg/m2 or higher

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of common diseases
Tidsram: 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)
Around each 5 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Frits R Rosendaal, Department of Clinical Epidemiology, Leiden University Medical Center
  • Studierektor: Renée de Mutsert, Department of Clinical Epidemiology, Leiden University Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 augusti 2008

Primärt slutförande (Förväntat)

1 september 2033

Avslutad studie (Förväntat)

1 september 2033

Studieregistreringsdatum

Först inskickad

10 januari 2018

Först inskickad som uppfyllde QC-kriterierna

18 januari 2018

Första postat (Faktisk)

25 januari 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 mars 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 mars 2019

Senast verifierad

1 februari 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • P08.109

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

This is a publicly funded observational study, all data are owned by the university and open to researchers after consultation and according to internal procedures

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Fetma

Kliniska prövningar på Inget ingripande

3
Prenumerera