NHS Digital Data Release Register - reformatted
Hull And East Yorkshire Hospitals NHS Trust
Project 1 — DARS-NIC-392244-H3M3G
Opt outs honoured: N, Y
Sensitive: Non Sensitive, and Sensitive
When: 2016/09 — 2017/02.
Legal basis: Section 251 approval is in place for the flow of identifiable data
- MRIS - Flagging Current Status Report
- MRIS - Cause of Death Report
Obesity, through insulin resistance, is a potent risk factor for Type 2 diabetes mellitus (T2DM). Obesity accounts for 80% of the overall risk of developing T2DM and appears to be the main cause of its increasing worldwide prevalence. In the UK, obesity is predicted to affect 60 per cent of adult men and 50 per cent of adult women by 2050 and, if this is true, then the prevalence of T2DM will also increase. The association between obesity and the increased risk of cardiovascular disease (CVD) is well established in the general population. However, once CVD is established, obesity seems to confer a paradoxical benefit. There is growing evidence that overweight patients with CVD survive longer than their normal-weight counterparts; an effect called the “obesity paradox”. Although obesity has been shown to account for much of the risk of developing T2DM, a similar obesity paradox may exist in this condition too. However, results are more conflicting for diabetic patients, with studies alternating between positive and negative associations between CVD, mortality and Body Mass Index (BMI), or other weight indexes. Biased populations, inadequate study power and incomplete adjustment for comorbidities may be some of the reasons behind this inconsistency among the reported studies to date. The aim of this study is to assess the relationship of obesity, CVD and mortality in Diabetes Mellitus, by addressing some of the issues that might have accounted for the inconsistent results in other studies. This study has already published findings in a prestigious international medical journal that demonstrate that overweight patients with type II diabetes mellitus have a better survival rate than those with normal weight (P. Costanzo et al Annals of Internal Medicine 2015;162:610-8). The study requires ONS mortality data for analysis building on the published work. Checking the cause of mortality of the study cohort will improve understanding of the observed relationship between obesity and all-cause mortality in patients with Type II Diabetes Mellitus. Cause of death data from the ONS would provide insights on what aspect of diabetes was driving the higher mortality amongst patients with diabetes who were not obese. For example, the study has shown that the obese patients had more cardiovascular events but, paradoxically, had a better prognosis. This raises the question: Are obese patients less prone to sudden death from their cardiovascular event and therefore more likely to turn up to hospital with a heart attack? Alternatively, cardiovascular deaths may also be higher in obese patients but perhaps they are much less likely to die of cancer or infection.
The study aims to provide more evidence on the relationship between body weight, morbidity and mortality in Diabetes Mellitus in order to improve understanding and treatment of the risks associated. There is a perception that patients with diabetes and normal weight are healthier than overweight patients with diabetes but this has shown that the reverse may be true. Understanding this is key to providing appropriate treatment. This research could make a difference to the care of millions of people with diabetes and ensure better use of NHS and research spend and resources. The medical fraternity and many members of the public will benefit from the dissemination of the study findings and these will inform research that leads to better care. Several eminent clinical scientists have asked whether we have information on cause of death (cancer, cardiovascular, respiratory etc). It is their questions and a wide international audience that the study seeks to satisfy. Knowing what patients within this study cohort died from could make a huge difference in understanding the clearly important relationship between weight and diabetes and potentially shine further light which in the long term might help improving the care of people with diabetes. The published findings were highlighted in the public media such as “The Times” and many other journals, in view of its novelty.
Research results will be published in scientific journals and presented at scientific conferences. No record level data will be included in any publication or presentation. These will be showed only as aggregated numbers with small numbers suppressed in line with the HES analysis guide. Record level data will be only accessible to the principal investigator of the study. Journals may include: the Annals of Internal Medicine; the Lancet: JAMA: Circulation and maybe others (it might vary according to the journals interest about this research). Conferences may include: the European Society of Cardiology Congress; the American College of Cardiology Conference; the American Heart Association Conference, and the British Cardiovascular Society Conference. The timeframe for completing the entire work including the main projects and subsequent sub-studies will be 1 year.
The Diabetes Centre at Hull and East Yorkshire Trust holds a clinical registry of about 12,000 patients with Diabetes Mellitus. Identifiable data including full name, date of birth, NHS number will be shared with the HSCIC and the HSCIC will link the data to mortality data from the Office for National Statistics (ONS). HSCIC will return the linked data to the Diabetes Centre at Hull and East Yorkshire Trust who will remove any identifiers and use unique patient pseudonyms (key codes) to match it to pseudonymised patient records within the clinical registry. The data will be analysed to investigate links between the body weight and morbidity and mortality data. The access to the clinical register is restricted to only the approved researcher involved in this project, based at the Hull and East Yorkshire Trust. No data supplied by HSCIC will be accessible to third parties.