Clinical trial NCT03191227: The Cork and Kerry Diabetes and Heart Disease Study (Phase II) Mitchelstown Cohort
Official title: The Cork and Kerry Diabetes and Heart Disease Study (Phase II)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Diabetes
Obesity
Hypertension
Dyslipidemia
Metabolic Syndrome
Diet Habit
Life Style
Physical Activity
Smoking
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: Livinghealth Clinic Mitchelstown
First posted: 2017-06-19
Enrollment: 2047
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment was completed on a new cohort of 2047 men and women aged 50-69 years from patients attending a single large primary care centre, the Living Health Clinic in Mitchelstown, a town with a population of 43000 in county Cork. The Living Health clinic includes eight GPs, and the practice serves a catchment area of 20 000, with a mix of urban and rural residents. Participants were randomly selected from all registered attending patients in the 50-69-year age group (response rate: 67%).

Brief summary: The aim of the Cork and Kerry Study Phase II (Mitchelstown cohort recruited 2010-11) is to provide an updated profile of glucose tolerance status, cardiovascular health and their related factors in an Irish adult general population sample and to compare the findings with those obtained during baseline assessment of Phase I of the Cork and Kerry study (1998) and the rescreen (2008).

Detailed description: Additional objectives include determining the prevalence of proximal risk factors, such as hypertension, dyslipidaemia, body mass index (BMI) and insulin resistance as well as of more distal risk factors of diet, smoking, alcohol consumption and physical activity, and the association between cardiovascular health and its risk factors with general measures of well-being and mental health. The new cohort includes collection of qualitative and quantitative data in an effort not only to describe the current health status of the cohort and assess individual level determinants but also to provide the appropriate context to interpret the role of behavioural factors and social circumstances on health.

Recruitment was completed on a new cohort of 2047 men and women aged 50-69 years from patients attending a single large primary care centre, the Living Health Clinic in Mitchelstown, a town with a population of 43000 in county Cork. The Living Health clinic includes eight GPs, and the practice serves a catchment area of 20 000, with a mix of urban and rural residents. Participants were randomly selected from all registered attending patients in the 50-69-year age group.

Eligibility criteria: Inclusion Criteria:

All participants from the Livinghealth Clinic practice list in the 50-69 year age bracket

Exclusion Criteria:

Duplicates, deaths and ineligibles and those who did not complete the general health questionnaire and physical examination

Primary outcomes:
measure: Cardiovascular disease
timeFrame: At baseline
measure: Type 2 Diabetes
timeFrame: At baseline
measure: Obesity
timeFrame: At baseline
measure: Hypertension
timeFrame: At baseline
measure: Metabolic syndrome
timeFrame: At baseline
Secondary outcomes:
measure: Depressive symptoms
timeFrame: At baseline
measure: Anxiety
timeFrame: At baseline
Other outcomes:
Locations:
Study officials:
affiliation: University College Cork
name: Ivan J Perry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kearney PM, Harrington JM, Mc Carthy VJ, Fitzgerald AP, Perry IJ. Cohort profile: The Cork and Kerry Diabetes and Heart Disease Study. Int J Epidemiol. 2013 Oct;42(5):1253-62. doi: 10.1093/ije/dys131. Epub 2012 Sep 14. No abstract available.