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

June 15, 2017 updated by: Catherine Phillips, University College Cork

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2047

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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%).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiovascular disease
Time Frame: At baseline
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.
At baseline
Type 2 Diabetes
Time Frame: At baseline
Type 2 diabetes was defined according to the American Heart Association guidelines of fasting plasma glucose (FPG) ≥ 7 mmol/L or doctor diagnosed diabetes.
At baseline
Obesity
Time Frame: At baseline
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.
At baseline
Hypertension
Time Frame: At baseline
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.
At baseline
Metabolic syndrome
Time Frame: At baseline
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).
At baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: At baseline
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.
At baseline
Anxiety
Time Frame: At baseline
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.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College Cork

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Livinghealth Clinic Mitchelstown

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ivan J Perry, MD, PhD, University College Cork

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRC/2007/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Study Data/Documents

  1. Study Protocol
    Information comments: Cohort profile

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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