Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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21 August 2017 |
Main ID: |
ISRCTN33032170 |
Date of registration:
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03/04/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study on the prevalence and determinants of glucose intolerance in a Dutch caucasian population: the Hoorn Study
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Scientific title:
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Prospective observational study on the prevalence and determinants of glucose intolerance in a Dutch caucasian population: the Hoorn Study |
Date of first enrolment:
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01/01/1989 |
Target sample size:
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2484 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN33032170 |
Study type:
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Observational |
Study design:
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Prospective observational study with five follow-up visits during a 25-year period, and ongoing registry of morbidity and mortality (Other)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Joline
Beulens |
Address:
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De Boelelaan 1089a
1081 HV
Amsterdam
Netherlands |
Telephone:
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+31 (0)20 4440367 |
Email:
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j.beulens@vumc.nl |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Men and women 2. Aged 50–75 years 3. Randomly selected from the municipal registry
Exclusion criteria: Participants with a non-Caucasian background
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Impaired glucose metabolism and type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
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Intervention(s)
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Between the years 1989 and 1992, a population-based survey of glucose tolerance was performed in the Dutch city of Hoorn in the West-Friesland region of the Netherlands. During this baseline measurement, information was obtained on, among others, glucose metabolism, diabetes-related risk factor levels and complaints, lifestyle, dietary intake, and demographic variables.
Physical re-examinations, repeating the measurements at baseline with additional extensive measurement to assess diabetes complications, were conducted in 1990-1991, 1996-1998, 2000-2001, 2005-2007, and 2007-2009.
All visits have corresponding measurements, including glucose metabolism determined by fasting plasma glucose, 75-g Oral Glucose Tolerance Test and HbA1c; anthropometrics; blood plasma lipid levels; albumin/creatinine ratio; blood pressure; family history of diabetes, self-reported medication use, disease history, diabetes-related complaints, lifestyle determinants and socio-economic status.
Finally, in addition to physical follow-up visits, all participants are still actively followed up for vital status by linkage with the municipality register and for occurrence of cardiovascular disease, cancer and cause-specific mortality, by checking their medical records.
In subsamples of the cohort, extensive physical diabetes complications have been measured, such as a retinopathy screening, autonomic function tests, peripheral neuropathy, ankle-arm pressure-ratio, echo-doppler scanning van de carotis and electrocardiography. In all visits additional measurements have been conducted, which vary from visit to visit.
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Primary Outcome(s)
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Disturbances in glucose metabolism, measured by fasting plasma glucose, 75-g Oral Glucose Tolerance Test and HbA1c at baseline and at the two follow-up measurements in 2010-2011 and 2013-2015
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Secondary Outcome(s)
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1. Depressive symptoms, measured using CES-D questionnaire at baseline and 7 year follow up 2. Quality of life, measured using questionnaires at baseline and 7 year follow up 3. Cardiovascular complications of diabetes, measured by a check of the medical records of the participants every 3 years
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Source(s) of Monetary Support
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VU University Medical Center of Amsterdam, Nederlandse Organisatie voor Wetenschappelijk Onderzoek, ZonMw, European Union, Novartis Pharma, Diabetes Fonds, Netherlands Heart Foundation
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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