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临床试验/NCT03221127
NCT03221127进行中(未招募)不适用

Kuopio Ischaemic Heart Disease Risk Factor Study (Nutrition Component)

University of Eastern Finland0 个研究点目标入组 2,682 人开始时间: 2017年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,682
主要终点
Carotid atherosclerosis

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
42 Years 至 73 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Condition that prevented visit at study clinic

结局指标

主要结局

Carotid atherosclerosis

时间窗: From baseline to 4-y, 11-y and 20-y examinations

Progression of common carotid artery - intima-media thickness (CCA-IMT)

Cardiovascular disease

时间窗: Annually between March 1984 and December 2052

Incidence of cardiovascular disease

Death

时间窗: Annually between March 1984 and December 2052

Incidence of death

次要结局

  • Type 2 diabetes(Annually between March 1984 and December 2052)
  • Dementia(Annually between March 1984 and December 2052)
  • Infectious disease(Annually between March 1984 and December 2052)
  • Cancer(Annually between March 1984 and December 2052)

研究者

申办方类型
Other
责任方
Sponsor

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