Ely CathedralThis picture is displayed with the kind permission of Derek Langley Darkness & Light Photography© |
Study RationaleThe Ely study was commenced in 1990 as a prospective population-based cohort study of the aetiology and pathogenesis of Type 2 Diabetes and related metabolic disorders with the aims of :
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Background
At the start of the project, the population of the city of Ely, Cambridgeshire (about 12000) and its surrounding villages was served by one general practice which had run a diabetic clinic and maintained a practice-based diabetes register over some years. The total practice list size at the end of February 1990 (just before the study began) was 15920. After a local media campaign and a public meeting the project was launched in the following month. The 4922 individuals registered with the practice and aged 40-64 years of age on 1 March 1990 formed the sampling frame from which participants were selected.
Current status
Phase I & Phase II
- Between 1990-1992, participants were randomly sampled from the practice list. People were ineligible if they were known to have been treated with insulin, had moved from the practice area before being contacted or were physically unable to come to the testing site. In total, 1122 people were examined (height, weight, blood pressure, blood sample collection) and completed an oral glucose tolerance test. Of these, 51 (4.5%) were classified as having newly diagnosed diabetes and 188 (16.8%) had impaired glucose intolerance.
- Between 1994-1996, 937 of the 1071 people who had been non-diabetic at baseline were re-examined in a 4.5 year follow-up study. This study showed that individuals with a family history of diabetes who are in the highest quartile for fasting glucose and total proinsulin have a 30% risk of progressing to diabetes in 4.5 years. This provides a mean of identifying a high-risk sub-group who might benefit from preventive intervention. A particular focus of this study was on the quantification of the role of physical activity in the aetiology of glucose intolerance and related disorders. Using the heart rate monitoring method with individual calibration of the relationship between energy expenditure and heart rate, a quantitative assessment of each participant’s physical activity level was made.
Phase III
- We are now (2000-2002) in the process of approaching the participants for a third time, 5.5 years after the Phase 2 follow-up to provide 10 year follow-up data on the original cohort. The specific aim of Phase 3 is to quantify the prospective relationship between habitual energy expenditure, as measured by valid and objective tools, and change in body weight, body composition and related metabolic abnormalities.
Ely Retrospective
- We are also taking the opportunity at this time-point to invite people for assessment, who were not originally invited in Phase 1 and those who refused invitation at Phase 1. The purpose of this is to help determine whether earlier detection and treatment of hyperglycaemia and related metabolic abnormalities provides actual benefit
- As both these groups, and the existing Ely cohort, will have been randomly selected from the same population-based sampling frame, this design equates to a ten year randomised controlled trial of screening, with retrospective data collection. This study design should, in about three years, provide valuable information about the costs and benefits of screening for diabetes at a tiny fraction of the cost of a prospective study
Statement of Ethics and Confidentiality
All of the studies conducted by the Diabetes Epidemiology Research Group have received ethical clearance from the local ethics committee