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Kuopio Ischaemic Heart Disease Risk Factor Study (Nutrition Component)

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ClinicalTrials.gov Identifier: NCT03221127
Recruitment Status : Active, not recruiting
First Posted : July 18, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
University of Eastern Finland

Brief Summary:
To determine associations between dietary factors and risk of major chronic diseases and their risk factors

Condition or disease
Cardiovascular Diseases Diabetes Metabolic Syndrome Cancer Inflammatory Disease Atherosclerosis Cognitive Decline Liver Diseases Death Pain, Chronic Depression Infection Chronic Disease

Detailed Description:

STUDY POPULATION The Kuopio Ischaemic Heart Disease Risk Factor Study (KIHD) is an on-going prospective, population-based cohort study of risk factors for cardiovascular diseases, other chronic diseases and metabolic conditions in a sample of men from eastern Finland. The baseline examinations were carried out between 1984 and 1989, when 2,682 men (82.9% of those eligible) who were 42, 48, 54 or 60 years old were recruited. The first cohort consisted of 1166 men who were 54 years old, enrolled in 1984-1986, and the second cohort included 1516 men who were 42, 48, 54 or 60 years old, enrolled in 1986-1989. The baseline examinations were followed by the 4-year examinations (1991-1993), in which 1038 men from the second cohort (88% of the eligible) participated. At the 11-year examinations (1998-2001), all men from the second cohort were invited and 854 men (95% of the eligible) participated. These examinations were also the baseline for 920 postmenopausal women (78.4% of the 1173 eligible women) from the same area, aged 53-73 years. During the 20-year examination round, all men from the first and second baseline cohorts and all women were invited to the study site, and a total of 1241 men (80% of the eligible) and 634 women (81.0%) participated.

ASSESSMENT OF DIETARY INTAKES Food consumption has been assessed with an instructed food recording of four days, one of which was a weekend day, by household measures. A picture book of common foods and dishes was used to help in estimation of portion sizes. For each food item the participant could choose from 3-5 commonly used portion sizes or describe the portion size in relation to those in the book. In order to further improve accuracy, instructions were given and completed food records were checked by a nutritionist together with a participant. Nutrient intakes were estimated using the NUTRICA® 2.5 software (Social Insurance Institution, Turku, Finland). The databank of the software is mainly based on Finnish values of nutrient composition of foods.

OUTCOME ASSESSMENT Registration of the incidence of major chronic diseases and deaths during the follow up is based on the national registries (Hospital discharge registry, Cause of death register, Social Insurance Institution of Finland register for reimbursement of medicine expenses) by use of the Finnish personal identification code (social security number), and/or on findings at the re-examination rounds (such as fasting plasma glucose or 2-h oral glucose tolerance test to define type 2 diabetes in addition to data from the national registries).


Study Type : Observational
Actual Enrollment : 2682 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Kuopio Ischaemic Heart Disease Risk Factor Study (Nutrition Component)
Actual Study Start Date : March 1, 1984
Estimated Primary Completion Date : December 31, 2052
Estimated Study Completion Date : December 31, 2052

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. Cardiovascular disease [ Time Frame: Annually between March 1984 and December 2052 ]
    Incidence of cardiovascular disease

  2. Carotid atherosclerosis [ Time Frame: From baseline to 4-y, 11-y and 20-y examinations ]
    Progression of common carotid artery - intima-media thickness (CCA-IMT)

  3. Death [ Time Frame: Annually between March 1984 and December 2052 ]
    Incidence of death


Secondary Outcome Measures :
  1. Type 2 diabetes [ Time Frame: Annually between March 1984 and December 2052 ]
    Incidence of type 2 diabetes

  2. Dementia [ Time Frame: Annually between March 1984 and December 2052 ]
    Incidence of dementia

  3. Cancer [ Time Frame: Annually between March 1984 and December 2052 ]
    Incidence of cancer

  4. Infectious disease [ Time Frame: Annually between March 1984 and December 2052 ]
    Incidence of hospitalization due infectious disease


Biospecimen Retention:   Samples With DNA
Blood, serum, plasma, urine, hair, nails, DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
See "Detailed description"
Criteria

Inclusion Criteria:

  • Aged 42, 48, 54 or 60 years (men at baseline in 1984-1989)
  • Aged 53 to 73 years (women at their baseline in 1998-2001)
  • Living in the city of Kuopio or neighboring rural areas

Exclusion Criteria:

  • Condition that prevented visit at study clinic

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): NCT03221127


Sponsors and Collaborators
University of Eastern Finland
Investigators
Principal Investigator: Jussi Kauhanen, MD, PhD University of Eastern Finland, Institute of Public Health and Clinical Nutrition

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Eastern Finland
ClinicalTrials.gov Identifier: NCT03221127     History of Changes
Other Study ID Numbers: KIHD Nutrition
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data available for collaborative projects

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Metabolic Syndrome X
Liver Diseases
Atherosclerosis
Chronic Disease
Myocardial Ischemia
Coronary Artery Disease
Cognitive Dysfunction
Chronic Pain
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes
Coronary Disease
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms