- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03191227
The Cork and Kerry Diabetes and Heart Disease Study (Phase II) Mitchelstown Cohort (Mitchelstown)
The Cork and Kerry Diabetes and Heart Disease Study (Phase II)
Study Overview
Status
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Ivan J Perry, MD, PhD, University College Cork
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRC/2007/13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
-
Study Protocol
Information comments: Cohort profile
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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