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

NCT03191227 | Completed

• 1 other identifier: HRC/2007/13
• Study Type: observational
• Target: 2,047
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cardiovascular Diseases; Diabetes; Obesity; Hypertension; Dyslipidemia; Metabolic Syndrome; Diet Habit; Life Style; Physical Activity; Smoking

Outcome Measures

Primary Outcomes (5)

• 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.

  At baseline

• 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.

  At baseline

• 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.

  At baseline

• 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.

  At baseline

• 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).

  At baseline

Secondary Outcomes (2)

• Depressive symptoms

  At baseline

• Anxiety

  At baseline

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University College Cork: lead
• Livinghealth Clinic Mitchelstown: collaborator

Related Publications (1)

• 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.

  PMID: 22984148 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Obesity; Hypertension; Dyslipidemias; Metabolic Syndrome; Feeding Behavior; Motor Activity; Smoking

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Lipid Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Behavior, Animal; Behavior

Study Officials

• Ivan J Perry, MD, PhD

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Catherine Phillips, Senior Research Fellow and Co-Principal Investigator

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 19, 2017
• Study Start: April 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share