Diabetes is a condition where the body cannot keep blood sugar at a normal level. When blood sugar levels are high for long periods of time, blood vessels and cells of the heart can become damaged, which can lead to a heart attack and even death. Adults with diabetes are two to three times more likely to develop heart disease. Recent studies have shown that the blood sugar levels in some people with diabetes can recover to normal without any diabetes medication. This can happen when a large amount of weight is lost through different methods. When this happens, the condition is called diabetes ‘remission’ which can last or may change back to diabetes again, which is called ‘relapse’. What we don’t know is how being in ‘remission’ or ‘relapse’ affects the chances of developing heart diseases, compared to the people who continue to have diabetes. In this study we aim to: 1)Find out how many people in the UK are in or have been in diabetes remission and how frequently relapse happens. 2)Compare the health (blood pressure, cholesterol level, other illnesses and treatments) of people in remission, relapse and those who continue to have diabetes. 3)Explore what things increase the chances of developing heart disease in people with remission or relapse and how these might be different to people who continue to have diabetes. This study is important in helping us understand what increase the chances of developing heart disease in people in diabetes remission and those who relapse.
Background
T2D-remission, achieved without clinical intervention such as bariatric surgery, is a relatively new phenomenon. [1] There is growing evidence that remission of T2D is feasible following significant weight-loss, by intensive lifestyle interventions [2-4] and there is emerging evidence of remission induced in people with new-onset T2D via intensive pharmacological treatment.[5, 6] Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in people living with T2D,[7] who develop CVD approximately 15 years earlier than their non-T2D counterparts.[8]However, the medium and long-term impact of remission on heart health and mortality are unknown and no clinical guidelines for the treatment or management of those in remission exist in the UK.
Design
Retrospective cohort design
Methods
Phase 1: Patients, aged ≥ 18years, with a new diagnosis of T2D without prior CVD, will be explored in CPRD and Hospital records. Within this group the incidence and timing of remission according to patient factors, clinical characteristics (treatments and morbidities) and year of diabetes diagnosis will be investigated.
Phase 2: In patients with a first remission, we will investigate the frequency of relapse over time, time to first relapse and risk factors of relapse.
Phase 3: The association between remission, relapse and the incidence of CVD and major adverse cardiovascular events will be estimated, and compared to those with persistent diabetes.
Outcomes: It is important to gather current evidence to the epidemiology and clinical characteristics of diabetes remission and remission-relapse and to quantify their association with CVD. This data will inform clinical guidelines for the prevention and management of CVD in this under-researched growing patient population.
(1) Prevalence of T2D remission
(2) Frequency of diabetes relapse
(3) Identify key patient, clinical and treatment factors associated with T2D- remission and relapse
(4) Quantify CVD risk (incidence and time to first- index of CVD, incidence of and time to first diagnosis of major adverse cardiovascular events (MACE) and time to fatal and non-fatal CVD hospital admission, in people in T2D-remssion and those that relapse, compared to people with persistent T2D
Claire Lawson - Chief Investigator - University of Leicester
YANAN SONG - Corresponding Applicant - University of Leicester
Emer Brady - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Claire Lawson - Collaborator - University of Leicester
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation