Protocol for ADDITION-PRO: a longitudinal cohort study of the cardiovascular experience of individuals at high risk for diabetes recruited from Danish primary care

Abstract

BackgroundScreening programmes for type 2 diabetes inevitably find more individuals at high risk for diabetes than people with undiagnosed prevalent disease. While well established guidelines for the treatment of diabetes exist, less is known about treatment or prevention strategies for individuals found at high risk following screening. In order to make better use of the opportunities for primary prevention of diabetes and its complications among this high risk group, it is important to quantify diabetes progression rates and to examine the development of early markers of cardiovascular disease and microvascular diabetic complications. We also require a better understanding of the mechanisms that underlie and drive early changes in cardiometabolic physiology. The ADDITION-PRO study was designed to address these issues among individuals at different levels of diabetes risk recruited from Danish primary care.Methods/DesignADDITION-PRO is a population-based, longitudinal cohort study of individuals at high risk for diabetes. 16,136 eligible individuals were identified at high risk following participation in a stepwise screening programme in Danish general practice between 2001 and 2006. All individuals with impaired glucose regulation at screening, those who developed diabetes following screening, and a random sub-sample of those at lower levels of diabetes risk were invited to attend a follow-up health assessment in 2009–2011 (n = 4,188), of whom 2,082 (50%) attended. The health assessment included detailed measurement of anthropometry, body composition, biochemistry, physical activity and cardiovascular risk factors including aortic stiffness and central blood pressure. All ADDITION-PRO participants are being followed for incident cardiovascular disease and death.DiscussionThe ADDITION-PRO study is designed to increase understanding of cardiovascular risk and its underlying mechanisms among individuals at high risk of diabetes. Key features of this study include (i) a carefully characterised cohort at different levels of diabetes risk; (ii) detailed measurement of cardiovascular and metabolic risk factors; (iii) objective measurement of physical activity behaviour; and (iv) long-term follow-up of hard clinical outcomes including mortality and cardiovascular disease. Results will inform policy recommendations concerning cardiovascular risk reduction and treatment among individuals at high risk for diabetes. The detailed phenotyping of this cohort will also allow a number of research questions concerning early changes in cardiometabolic physiology to be addressed.

Physical activity energy expenditure vs cardiorespiratory fitness level in impaired glucose metabolism

“…Participants who were physically impaired or had certain cardiovascular conditions, e.g. angina pectoris, were excluded from the step test [21].…”

“…The participants were asked to wear the monitor for 7 days and nights and to maintain their usual physical activity level. Only measures from participants with a minimum of 24 h of combined monitor wear time were considered valid for the present analysis [21].…”

“…At the health assessment, participants completed a health questionnaire about general health status including smoking status (current smoker, never smoker, ex-smoker) and alcohol consumption (units per week) [21]. Height was measured without shoes to the nearest millimetre using a stadiometer (Seca, Hamburg, Germany).…”

“…A total of 4,188 individuals without type 2 diabetes were invited to participate in a follow-up health examination, the ADDITION-PRO study. Of these, 2,082 (~50% of those invited) completed the health examination, which took place from 2009 to 2011 at four centres in Denmark [21]. The ADDITION-PRO study has been described in detail elsewhere [21].…”

“…Waist circumference was measured to the nearest millimetre, at the mid-point between the lower costal margin and the level of the anterior superior iliac crest. Waist circumference was measured twice by the same person and the mean value was used [21,22].…”