UK Imaging Diabetes Study Seeing Diabetes Clearly

Diabetic Retinopathy Clinical Trial

— UKIDS  

Official title:

UK Imaging Diabetes Study Seeing Diabetes Clearly

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05057403
• Other study ID #: 20/WM/0007
• Status: Enrolling by invitation
• Start date: May 30, 2022
• Est. completion date: June 2034

Study information

• Verified date: April 2023
• Source: Perspectum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 10 years, in patients diagnosed with type 2 diabetes and concurrent diabetic retinopathy (as per their standard of care).

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 10 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 multiparametric MRI scan. Both visits will be within 21 days of the screening visit and carried out at local study sites.

Clinical outcome measurements, blood samples and urine samples will be collected to assess the natural history of diabetes disease progression. Optional blood sample will be collected for future genetic testing. Participants will be asked to give consent for access to their medical records held at their local hospital and NHS England to obtain information on Hospital admissions (Hospital Episode Statistics), and mortality data collected by the Office for National Statistics (ONS), also provided by NHS England. This data will be collected at 1, 3 and 10 years after baseline assessment.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: June 2034
• Est. primary completion date: June 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, at least 18 years of age and diagnosed with type 2 diabetes and 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 of unstable angina

• heart surgery

• unstable angina

• transient ischaemic 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy
• Type2 Diabetes

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Perspectum	Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-point MACE incidence rate	Investigate the effect of baseline liver magnetic resonance (MR) metrics on the incidence rate of 3-point major adverse cardiovascular events (MACE) (cardiovascular death, non-fatal stroke, myocardial infarction)	1 year from baseline
Primary	3-point MACE incidence rate	Investigate the effect of baseline liver magnetic resonance (MR) metrics on the incidence rate of 3-point major adverse cardiovascular events (MACE) (cardiovascular death, non-fatal stroke, myocardial infarction)	3 years from baseline
Primary	3-point MACE incidence rate	Investigate the effect of baseline liver magnetic resonance (MR) metrics on the incidence rate of 3-point major adverse cardiovascular events (MACE) (cardiovascular death, non-fatal stroke, myocardial infarction)	10 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of heart failure	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of heart failure.	1 year from baseline
Secondary	Effect of body composition MRI metrics on incidence of heart failure	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of heart failure.	3 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of heart failure	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of heart failure.	10 years from baseline
Secondary	Effect of liver MRI metrics on incidence of heart failure	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of heart failure.	1 year from baseline
Secondary	Effect of liver MRI metrics on incidence of heart failure	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of heart failure.	3 years from baseline
Secondary	Effect of liver MRI metrics on incidence of heart failure	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of heart failure.	10 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of heart failure	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of heart failure.	1 year from baseline
Secondary	Effect of aortic health MRI metrics on incidence of heart failure	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of heart failure.	3 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of heart failure	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of heart failure.	10 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of hospitalisation for cardiovascular causes	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of hospitalisation for cardiovascular causes.	1 year from baseline
Secondary	Effect of body composition MRI metrics on incidence of hospitalisation for cardiovascular causes	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of hospitalisation for cardiovascular causes.	3 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of hospitalisation for cardiovascular causes	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of hospitalisation for cardiovascular causes.	10 years from baseline
Secondary	Effect of liver MRI metrics on incidence of hospitalisation for cardiovascular causes	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of hospitalisation for cardiovascular causes.	1 year from baseline
Secondary	Effect of liver MRI metrics on incidence of hospitalisation for cardiovascular causes	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of hospitalisation for cardiovascular causes.	3 years from baseline
Secondary	Effect of liver MRI metrics on incidence of hospitalisation for cardiovascular causes	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of hospitalisation for cardiovascular causes.	10 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of hospitalisation for cardiovascular causes	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of hospitalisation for cardiovascular causes.	1 year from baseline
Secondary	Effect of aortic health MRI metrics on incidence of hospitalisation for cardiovascular causes	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of hospitalisation for cardiovascular causes.	3 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of hospitalisation for cardiovascular causes	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of hospitalisation for cardiovascular causes.	10 years from baseline
Secondary	Effect of body composition MRI metrics on renal disease events	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of composite severe renal disease events (renal replacement therapy, renal death), composite mild renal disease events (incident chronic kidney disease (CKD), change in stage of CKD).	1 year from baseline
Secondary	Effect of body composition MRI metrics on renal disease events	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of composite severe renal disease events (renal replacement therapy, renal death), composite mild renal disease events (incident chronic kidney disease (CKD), change in stage of CKD).	3 years from baseline
Secondary	Effect of body composition MRI metrics on renal disease events	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of composite severe renal disease events (renal replacement therapy, renal death), composite mild renal disease events (incident chronic kidney disease (CKD), change in stage of CKD).	10 years from baseline
Secondary	Effect of liver MRI metrics on renal disease events	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of composite severe renal disease events (renal replacement therapy, renal death), composite mild renal disease events (incident chronic kidney disease (CKD), change in stage of CKD).	1 year from baseline
Secondary	Effect of liver MRI metrics on renal disease events	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of composite severe renal disease events (renal replacement therapy, renal death), composite mild renal disease events (incident chronic kidney disease (CKD), change in stage of CKD).	3 years from baseline
Secondary	Effect of liver MRI metrics on renal disease events	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of composite severe renal disease events (renal replacement therapy, renal death), composite mild renal disease events (incident chronic kidney disease (CKD), change in stage of CKD).	10 years from baseline
Secondary	Effect of aortic health MRI metrics on renal disease events	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of composite severe renal disease events (renal replacement therapy, renal death), composite mild renal disease events (incident chronic kidney disease (CKD), change in stage of CKD).	1 year from baseline
Secondary	Effect of aortic health MRI metrics on renal disease events	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of composite severe renal disease events (renal replacement therapy, renal death), composite mild renal disease events (incident chronic kidney disease (CKD), change in stage of CKD).	3 years from baseline
Secondary	Effect of aortic health MRI metrics on renal disease events	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of composite severe renal disease events (renal replacement therapy, renal death), composite mild renal disease events (incident chronic kidney disease (CKD), change in stage of CKD).	10 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of retinal intervention	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections).	1 year from baseline
Secondary	Effect of body composition MRI metrics on incidence of retinal intervention	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections).	3 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of retinal intervention	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections).	10 years from baseline
Secondary	Effect of liver MRI metrics on incidence of retinal intervention	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections).	1 year from baseline
Secondary	Effect of liver MRI metrics on incidence of retinal intervention	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections).	3 years from baseline
Secondary	Effect of liver MRI metrics on incidence of retinal intervention	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections).	10 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of retinal intervention	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections).	1 year from baseline
Secondary	Effect of aortic health MRI metrics on incidence of retinal intervention	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections).	3 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of retinal intervention	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections).	10 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of amputations	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of lower limb amputations.	1 year from baseline
Secondary	Effect of body composition MRI metrics on incidence of amputations	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of lower limb amputations.	3 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of amputations	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of lower limb amputations.	10 years from baseline
Secondary	Effect of liver MRI metrics on incidence of amputations	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of lower limb amputations.	1 year from baseline
Secondary	Effect of liver MRI metrics on incidence of amputations	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of lower limb amputations.	3 years from baseline
Secondary	Effect of liver MRI metrics on incidence of amputations	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of lower limb amputations.	10 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of amputations	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of lower limb amputations.	1 year from baseline
Secondary	Effect of aortic health MRI metrics on incidence of amputations	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of lower limb amputations.	3 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of amputations	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of lower limb amputations.	10 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of death	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of all-cause mortality, cardiovascular death, liver death, renal death, cancer death.	1 year from baseline
Secondary	Effect of body composition MRI metrics on incidence of death	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of all-cause mortality, cardiovascular death, liver death, renal death, cancer death.	3 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of death	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of all-cause mortality, cardiovascular death, liver death, renal death, cancer death.	10 years from baseline
Secondary	Effect of liver MRI metrics on incidence of death	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of all-cause mortality, cardiovascular death, liver death, renal death, cancer death.	1 year from baseline
Secondary	Effect of liver MRI metrics on incidence of death	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of all-cause mortality, cardiovascular death, liver death, renal death, cancer death.	3 years from baseline
Secondary	Effect of liver MRI metrics on incidence of death	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of all-cause mortality, cardiovascular death, liver death, renal death, cancer death.	10 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of death	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of all-cause mortality, cardiovascular death, liver death, renal death, cancer death, other death.	1 year from baseline
Secondary	Effect of aortic health MRI metrics on incidence of death	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of all-cause mortality, cardiovascular death, liver death, renal death, cancer death, other death.	3 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of death	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of all-cause mortality, cardiovascular death, liver death, renal death, cancer death, other death.	10 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of liver events	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	1 year from baseline
Secondary	Effect of body composition MRI metrics on incidence of liver events	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	3 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of liver events	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	10 years from baseline
Secondary	Effect of liver MRI metrics on incidence of liver events	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	1 year from baseline
Secondary	Effect of liver MRI metrics on incidence of liver events	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	3 years from baseline
Secondary	Effect of liver MRI metrics on incidence of liver events	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	10 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of liver events	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	1 year from baseline
Secondary	Effect of aortic health MRI metrics on incidence of liver events	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	3 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of liver events	Investigate the effect of baseline MR metrics of aortic distensibility and aortic diameter on the incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	10 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of non-hepatic cancer	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of non-hepatic cancer.	1 year from baseline
Secondary	Effect of body composition MRI metrics on incidence of non-hepatic cancer	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of non-hepatic cancer.	3 years from baseline
Secondary	Effect of body composition MRI metrics on incidence of non-hepatic cancer	Investigate the effect of baseline MR metrics of whole body muscle and fat distribution on the incidence of non-hepatic cancer.	10 years from baseline
Secondary	Effect of liver MRI metrics on incidence of non-hepatic cancer	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of non-hepatic cancer.	1 year from baseline
Secondary	Effect of liver MRI metrics on incidence of non-hepatic cancer	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of non-hepatic cancer.	3 years from baseline
Secondary	Effect of liver MRI metrics on incidence of non-hepatic cancer	Investigate the effect of baseline MR metrics of liver volume and liver fat content on the incidence of non-hepatic cancer.	10 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of non-hepatic cancer	Investigate the effect of baseline MR metrics of aortic distensibility on the incidence of non-hepatic cancer.	1 year from baseline
Secondary	Effect of aortic health MRI metrics on incidence of non-hepatic cancer	Investigate the effect of baseline MR metrics of aortic distensibility on the incidence of non-hepatic cancer.	3 years from baseline
Secondary	Effect of aortic health MRI metrics on incidence of non-hepatic cancer	Investigate the effect of baseline MR metrics of aortic distensibility on the incidence of non-hepatic cancer.	10 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of 3-point MACE	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of 3-point MACE (cardiovascular death, non-fatal stroke, myocardial infarction).	1 year from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of 3-point MACE	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of 3-point MACE (cardiovascular death, non-fatal stroke, myocardial infarction).	3 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of 3-point MACE	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of 3-point MACE (cardiovascular death, non-fatal stroke, myocardial infarction).	10 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of heart failure	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of heart failure.	1 year from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of heart failure	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of heart failure.	3 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of heart failure	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of heart failure.	10 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of hospitalisation for cardiovascular causes	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of hospitalisation for cardiovascular causes.	1 year from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of hospitalisation for cardiovascular causes	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of hospitalisation for cardiovascular causes.	3 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of hospitalisation for cardiovascular causes	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of hospitalisation for cardiovascular causes.	10 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of composite renal events	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of composite severe renal events (renal replacement therapy, renal death) and composite mild renal events (incident chronic kidney disease (CKD), change in stage of CKD).	1 year from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of composite renal events	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of composite severe renal events (renal replacement therapy, renal death) and composite mild renal events (incident chronic kidney disease (CKD), change in stage of CKD).	3 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of composite renal events	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of composite severe renal events (renal replacement therapy, renal death) and composite mild renal events (incident chronic kidney disease (CKD), change in stage of CKD).	10 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of retinal intervention	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of retinal intervention (photocoagulation, Vity, use of anti-vascular endothelial growth factor injections).	1 year from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of retinal intervention	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of retinal intervention (photocoagulation, Vity, use of anti-vascular endothelial growth factor injections).	3 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of retinal intervention	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of retinal intervention (photocoagulation, Vity, use of anti-vascular endothelial growth factor injections).	10 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of amputation	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of lower limb amputations.	1 year from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of amputation	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of lower limb amputations.	3 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of amputation	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of lower limb amputations.	10 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of death	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of death (all-cause mortality, cardiovascular (CV) death, liver death, cancer death, other death.	1 year from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of death	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of death (all-cause mortality, cardiovascular (CV) death, liver death, cancer death, other death.	3 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of death	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of death (all-cause mortality, cardiovascular (CV) death, liver death, cancer death, other death.	10 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of liver events	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	1 year from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of liver events	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	3 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of liver events	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	10 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of non-hepatic cancer	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of non-hepatic cancer.	1 year from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of non-hepatic cancer	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of non-hepatic cancer.	3 years from baseline
Secondary	Potential associations of body composition, liver and aortic MRI metrics and incidence of non-hepatic cancer	Associations between whole body muscle and fat distribution, liver and aorta metrics and the incidence of non-hepatic cancer.	10 years from baseline
Secondary	Effect of retinopathy severity on incidence of 3-point MACE	Effect of retinopathy severity (mild non-proliferative diabetic retinopathy (NPDR), severe NPDR, proliferative diabetic retinopathy (PDR) and advanced PD) on incidence of 3-point MACE (cardiovascular death, non-fatal stroke, myocardial infarction).	1 year from baseline
Secondary	Effect of retinopathy severity on incidence of 3-point MACE	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of 3-point MACE (cardiovascular death, non-fatal stroke, myocardial infarction).	3 years from baseline
Secondary	Effect of retinopathy severity on incidence of 3-point MACE	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of 3-point MACE (cardiovascular death, non-fatal stroke, myocardial infarction).	10 years from baseline
Secondary	Effect of retinopathy severity on incidence of heart failure	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of heart failure.	1 year from baseline
Secondary	Effect of retinopathy severity on incidence of heart failure	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of heart failure.	3 years from baseline
Secondary	Effect of retinopathy severity on incidence of heart failure	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of heart failure.	10 years from baseline
Secondary	Effect of retinopathy severity on incidence of hospitalisation for cardiovascular causes	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of hospitalisation for cardiovascular causes.	1 year from baseline
Secondary	Effect of retinopathy severity on incidence of hospitalisation for cardiovascular causes	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of hospitalisation for cardiovascular causes.	3 years from baseline
Secondary	Effect of retinopathy severity on incidence of hospitalisation for cardiovascular causes	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of hospitalisation for cardiovascular causes.	10 years from baseline
Secondary	Effect of retinopathy severity on incidence of composite renal disease events	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of hospitalisation for composite severe renal disease events (renal replacement therapy, renal death) and composite mild renal disease events (incident of CKD, change in stage of CKD).	1 year from baseline
Secondary	Effect of retinopathy severity on incidence of composite renal disease events	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of hospitalisation for composite severe renal disease events (renal replacement therapy, renal death) and composite mild renal disease events (incident of CKD, change in stage of CKD).	3 years from baseline
Secondary	Effect of retinopathy severity on incidence of composite renal disease events	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of hospitalisation for composite severe renal disease events (renal replacement therapy, renal death) and composite mild renal disease events (incident of CKD, change in stage of CKD).	10 years from baseline
Secondary	Effect of retinopathy severity on incidence of retinal intervention	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of retinal intervention (photocoagulation, Vity, use of anti-vascular endothelial growth factor injections).	1 year from baseline
Secondary	Effect of retinopathy severity on incidence of retinal intervention	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of retinal intervention (photocoagulation, Vity, use of anti-vascular endothelial growth factor injections).	3 years from baseline
Secondary	Effect of retinopathy severity on incidence of retinal intervention	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of retinal intervention (photocoagulation, Vity, use of anti-vascular endothelial growth factor injections).	10 years from baseline
Secondary	Effect of retinopathy severity on incidence of amputation	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of lower limb amputations.	1 year from baseline
Secondary	Effect of retinopathy severity on incidence of amputation	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of lower limb amputations.	3 years from baseline
Secondary	Effect of retinopathy severity on incidence of amputation	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of lower limb amputations.	10 years from baseline
Secondary	Effect of retinopathy severity on incidence of death	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of all-cause mortality, CV death, liver death, renal death, cancer death, other death.	1 year from baseline
Secondary	Effect of retinopathy severity on incidence of death	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of all-cause mortality, CV death, liver death, renal death, cancer death, other death.	3 years from baseline
Secondary	Effect of retinopathy severity on incidence of death	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of all-cause mortality, CV death, liver death, renal death, cancer death, other death.	10 years from baseline
Secondary	Effect of retinopathy severity on incidence of liver events	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	1 year from baseline
Secondary	Effect of retinopathy severity on incidence of liver events	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	3 years from baseline
Secondary	Effect of retinopathy severity on incidence of liver events	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension).	10 years from baseline
Secondary	Effect of retinopathy severity on incidence of non-hepatic cancer	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of non-hepatic cancer.	1 year from baseline
Secondary	Effect of retinopathy severity on incidence of non-hepatic cancer	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of non-hepatic cancer.	3 years from baseline
Secondary	Effect of retinopathy severity on incidence of non-hepatic cancer	Effect of retinopathy severity (mild NPDR, severe NPDR, PDR and advance PD) on incidence of non-hepatic cancer.	10 years from baseline
Secondary	Liver metric and eye metric correlations	Correlations between liver MRI metrics (organ volume, fat infiltration and fibroinflammation) and eye metrics (retinal layer thickness by optical coherence tomography (OCT), discrete retinopathy scores).	10 years from baseline
Secondary	Non-alcoholic fatty liver disease prevalence	Prevalence of patients with evidence of non-alcoholic fatty liver disease in patients with diabetic retinopathy of different severity (mild non-proliferative diabetic retinopathy (NPDR), moderate NPDR, severe NPDR, proliferative diabetic retinopathy (PDR), advanced PD).	10 years after baseline