UK Imaging Diabetes Study Seeing Diabetes Clearly

This will be a multi-site study adopting a prospective, observational cohort study design. There will be no intervention to the standard of care. Study participants will be enrolled in this study for a total of 5 years, with only 1 month of active participation. Participants will be required to attend a screening visit and 2 study visits. The screening visit will involve a medical review and receiving informed consent based on the participant information leaflet already communicated to the patient, pre-screening. The first study visit- baseline (visit 1) - will involve anthropometric measurements and taking a blood and urine sample in order to perform standard of care measurements for type 2 diabetes at baseline and relevant circulating biomarkers. The second study visit will involve having a multi-organ, multiparametric MRI scan. Both visits will be within 28 days of the screening visit and carried out at local study sites.

MRI metrics of organ health, clinical outcome measurements, blood samples and urine samples will be collected to assess the natural history of diabetes disease progression. Participants will be asked to give consent for access to their medical records held at NHS England and, if available, at their local GP surgery or hospital. Medical records access will include Hospital admissions (Hospital Episode Statistics), and mortality data collected by the Office for National Statistics and provided by NHS England to meet the primary objective. This data will be collected at 1, 3 and 5 years after baseline assessment.

• The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death). [Time frame: 1 year from baseline]
• The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death). [Time frame: 3 years from baseline]
• The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death). [Time frame: 5 years from baseline]
• The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD) [Time frame: 1 year from baseline]
• The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD) [Time frame: 3 years from baseline]
• The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD) [Time frame: 5 years from baseline]
• The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections) [Time frame: 1 year from baseline]
• The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections) [Time frame: 3 years from baseline]
• The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections) [Time frame: 5 years from baseline]
• The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations [Time frame: 1 year from baseline]
• The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations [Time frame: 3 years from baseline]
• The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations [Time frame: 5 years from baseline]