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Cardiovascular DiseasesMitchelstownNCT03191227

The Cork and Kerry Diabetes and Heart Disease Study (Phase II) Mitchelstown Cohort

An observational study of Cardiovascular Diseases and Diabetes, run by University College Cork.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases, Diabetes, Obesity
How many people
2,047 participants
Where
No sites listed yet
Study dates
Apr 2010to May 2011
How long will I take part?
6 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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%).

Who may be able to join

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

Who cannot join

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

About this study

Official title: The Cork and Kerry Diabetes and Heart Disease Study (Phase II)

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).

Read the 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.

Medical subject headings
Cardiovascular Diseases, Diabetes Mellitus, Obesity, Hypertension, Dyslipidemias, Metabolic Syndrome, Feeding Behavior, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular disease

    The presence of cardiovascular disease (CVD) was obtained from the GHQ by asking study participants if they had been diagnosed with any one of the following seven conditions: Heart Attack (including coronary thrombosis or myocardial infarction), Heart Failure, Angina, Aortic Aneurysm, Hardening of the Arteries, Stroke, or any other Heart Trouble. Subjects who indicated a diagnosis of any one of these conditions were classified as having CVD.

    Measured: At baseline

  2. Type 2 Diabetes

    Type 2 diabetes was defined according to the American Heart Association guidelines of fasting plasma glucose (FPG) ≥ 7 mmol/L or doctor diagnosed diabetes.

    Measured: At baseline

  3. Obesity

    Anthropometric measurements were recorded with calibrated instruments according to a standardised protocol. Body weight was measured in kilograms without shoes; to the nearest 100g using a Tanita WB100MA® weighing scales (Tanita Corporation, IL, USA). Height was measured in centimetres to one decimal place using a Seca Leicester® height gauge (Seca, Birmingham, UK). BMI was calculated as weight (kg) /height (m)2. Individuals with a BMI ≥ 30kg/m2 were defined as obese.

    Measured: At baseline

  4. Hypertension

    Blood pressure was measured according to the European Society of Hypertension Guidelines using an Omron M7 Digital BP monitor on the right arm, after a 5-minute rest in the seated position. The average of the second and third measurements was used for analyses. Hypertension was defined as average systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg or being on hypertensive medication.

    Measured: At baseline

  5. Metabolic syndrome

    This is a composite measure classified using a range of MetS definitions (National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) 2001, 2004, American Diabetes Association, International Diabetes Federation) based on the following features: Waist circumference (WC), Fasting plasma glucose (FPG), High density lipoprotein cholesterol (HDL-C), Triglycerides (TG) and Blood pressure (BP).

    Measured: At baseline

Secondary outcomes (2)

  1. Depressive symptoms

    Depressive symptoms were assessed using the 20-item Centre for Epidemiologic Studies Depression Scale (CES-D) questionnaire which was designed to evaluate the frequency and severity of depressive symptoms. History of depression was assessed using the following questions: "Have you ever had depression?" Subjects were then asked "If yes, when did it start? In the last year/ 1-5 years ago/ >5 years ago." Data regarding antidepressant medication use were collected. In addition to use of the aforementioned screening tool, subjects who indicated a diagnosis of depression or current anti-depressant medication use were classified as having a mental health disorder.

    Measured: At baseline

  2. Anxiety

    Anxiety was assessed using the Hospital Anxiety and Depression Scale (HADS), using only the anxiety subscale. History of anxiety was assessed using the following questions: "Have you ever had anxiety?" Subjects were then asked "If yes, when did it start? In the last year/ 1-5 years ago/ >5 years ago." Data regarding antidepressant medication use were collected. In addition to use of the aforementioned screening tool, subjects who indicated a diagnosis of depression or anxiety or current anti-depressant medication use were classified as having a mental health disorder.

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2017
  2. Study startApr 2010
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
2,047 participants (actual)
Target duration
6 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03191227
Sponsor's protocol ID
HRC/2007/13
Acronym
Mitchelstown
Status last verified
Jun 2017
First submitted
12 Jun 2017
Last updated
19 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All collected source data are maintained and stored at the study research office, in the Department of Epidemiology and Public Health, University College Cork. Specific proposals for future collaboration would be welcomed. Further information can be found on the research centre website, http://www.hrbchdr.com/ or through email to patricia.kearney@ucc.ie.

Publications

  • 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.

    PubMed 22984148

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Diabetes, run by University College Cork.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular disease (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03191227, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2017.

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