Overview
Prospective, observational cohort study to cross-sectionally assess the health of multiple organs, using multiparametric abdominal magnetic resonance imaging (MRI) scan, and understand if resulting MRI metrics can predict future clinical events over a period of 5 years, in adult patients with type 2 diabetes lacking history of cardiovascular disease.
Description
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.
Eligibility
Inclusion Criteria:
- Male or female at least 18 years of age and diagnosed with type 2 diabetes, with or without diabetic retinopathy.
- Participant willing and able to give informed consent for participation in the study.
Exclusion Criteria:
In 12 months prior to consent, evidence of existing cardiovascular event defined as at least one of:
- myocardial infarction
- ischaemic stroke
- hospital admission/discharge for unstable angina
- heart surgery
- unstable angina
- transient ischemic attack
- The participant may not enter the study if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
- Patients with known autoimmune hepatitis, viral hepatitis, Wilson's disease or known significant structural renal tract abnormality.
- Patients with known alcohol dependency.
- Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study