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Dynamic Mediterranean Prospective Cohort: the SUN Project

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ClinicalTrials.gov Identifier: NCT02669602
Recruitment Status : Enrolling by invitation
First Posted : February 1, 2016
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary:
Dynamic prospective cohort of Spanish university graduates. The main objective is to evaluate the associations between nutrition and lifestyle and chronic diseases.

Condition or disease
Lifestyle Chronic Disease Dietary Habits

Detailed Description:

The SUN Project (University of Navarra Follow-Up Study) began in 1999, and currently more than 20,500 people participate. The Project is permanently open to new volunteers, and around 2,000 new participants are invited each year.

A new questionnaire is sent to participants every two years. The questionnaires are named with the letter "Q," followed by the number of years that have passed since the participant first volunteered. The first questionnaire is titled "Q0" and is followed by "Q2","Q4", etc.

The cohort is "dynamic" thanks to the fact that it is permanently open to new volunteers. Although the Project was created by the Department of Preventive Medicine and Public Health of the University of Navarra, it now counts on the invaluable collaboration of other Spanish university centers.

Thanks to the invaluable collaboration of our participants, the investigators are able to research cardiovascular diseases, depression, fertility, arterial hypertension, and car accident injuries, among other areas.


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Study Type : Observational
Actual Enrollment : 22500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Mediterranean Prospective Cohort: the SUN Project
Study Start Date : December 1999
Estimated Primary Completion Date : December 2050
Estimated Study Completion Date : December 2075

Group/Cohort
No intervention
No Intervention



Primary Outcome Measures :
  1. Mortality [ Time Frame: 50 years ]

Secondary Outcome Measures :
  1. Cardiovascular disease [ Time Frame: 50 years ]
    cardiovascular death, acute coronary syndromes (myocardial infarction with or without ST elevation), revascularization procedures or fatal or non-fatal stroke.

  2. Obesity [ Time Frame: 50 years ]
    BMI>30 kg/m2

  3. Depression [ Time Frame: 50 years ]
    Diagnosed depression through the Structured Clinical Interview (SCID-I) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)

  4. Cognitive function [ Time Frame: 50 years ]
    Telephone Interview of Cognitive Status-modified (TICS-m)


Biospecimen Retention:   Samples With DNA
Saliva


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Spanish university graduates
Criteria

Inclusion Criteria:

  • Spanish university graduates

Exclusion Criteria:

  • not Spanish university graduates

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669602


Locations
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Spain
University of Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
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Principal Investigator: Miguel A Martinez-Gonzalez, PhD University of Navarra

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT02669602     History of Changes
Other Study ID Numbers: SUN
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Nutritional epidemiology
Prospective
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes