Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Moorfields Eye Hospital NHS Foundation Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 diabetes | Patients with type 2 diabetes, especially individuals who have been diagnosed in the last three years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Other | MRI is not part of Pathway for patient with type two diabetes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline liver MR metrics on incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes) in people with type 2 diabetes, without history of CV. | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on cardiovascular clinical outcomes in a patient population with type 2 diabetes without history of cardiovascular disease. | 3 year from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
In 12 months prior to consent, evidence of existing cardiovascular event defined as at least one of:
Not provided
Not provided
Not provided
Adult participants, aged 18 years of age and over with type 2 diabetes lacking history of cardiovascular disease. Recruitment will be carried out from patients identified following diabetes or diabetic retinopathy diagnoses or via self-referral.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soubera Rymall, MSc | Contact | 00447919272482 | soubera.rymell@perspectum.com |
| Name | Affiliation | Role |
|---|---|---|
| Ravi Pattanshetty | Perspectum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodlands Medical Centre | Recruiting | Didcot | Oxfordshire | OX11 0BB | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Serum, white blood cells
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes |
| 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). | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 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) | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 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) | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 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) | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 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) | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 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) | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 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) | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 5 years from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 1 year from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 3 years from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 5 years from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 1 year from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 3 years from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 5 years from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 1 year from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 3 years from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 5 years from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension) | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 1 year from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension) | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 3 years from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension) | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 5 years from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 1 year from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 3 years from baseline |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes | 5 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 1 year from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase with incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 3 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase with incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 5 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death) | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 1 year from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death) | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 3 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death) | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 5 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD) | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 1 year from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD) | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 3 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD) | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 5 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections) | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 1 year from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections) | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 3 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections) | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 5 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 1 year from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 3 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 5 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 1 year from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 3 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 5 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of CV death, liver death, renal death, cancer death, other death | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 1 year from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of CV death, liver death, renal death, cancer death, other death | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 3 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of CV death, liver death, renal death, cancer death, other death | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 5 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension) | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 1 year from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension) | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 3 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension) | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 5 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 1 year from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 3 years from baseline |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer | The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI | 5 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes) | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes) | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes) | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite severe renal disease events (renal replacement therapy, renal death) | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite severe renal disease events (renal replacement therapy, renal death) | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite severe renal disease events (renal replacement therapy, renal death) | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite mild renal disease events (incident CKD, change in stage of CKD) | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite mild renal disease events (incident CKD, change in stage of CKD) | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite mild renal disease events (incident CKD, change in stage of CKD) | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections) | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections) | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections) | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of CV death, liver death, renal death, cancer death, other death | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of CV death, liver death, renal death, cancer death, other death | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of CV death, liver death, renal death, cancer death, other death | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes) | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes) | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes) | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death) | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death) | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death) | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD) | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD) | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD) | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections) | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections) | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections) | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of lower limb amputations | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of lower limb amputations | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of lower limb amputations | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of all-cause mortality | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of all-cause mortality | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of all-cause mortality | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of CV death, liver death, renal death, cancer death, other death | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of CV death, liver death, renal death, cancer death, other death | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of CV death, liver death, renal death, cancer death, other death | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of non-hepatic cancer | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 1 year from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of non-hepatic cancer | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 3 years from baseline |
| The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of non-hepatic cancer | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes | 5 years from baseline |
| Prevalence of patients with evidence of metabolic dysfunction-associated steatotic liver disease in patients with diabetic retinopathy of different severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) | The co-prevalence of diabetic retinopathy (DR) and metabolic dysfunction-associated steatotic liver disease (MASLD), using multi-parametric abdominal MRI | 1 year from baseline |
| Correlations between liver MRI metrics (organ volume, fat infiltration and fibroinflammation) and eye metrics (retinal layer thickness by OCT, discrete retinopathy scores) | The correlation between severity of eye disease and MRI-derived metrics of liver disease using multiparametric MRI | 1 year from baseline |
| Eynsham Medical Centre | Recruiting | Eynsham | Oxfordshire | OX29 4QB | United Kingdom |
|
| White Horse Medical Practice | Recruiting | Farringdon | Oxfordshire | SN7 7YU | United Kingdom |
|
| Windrush Medical Practice | Recruiting | Witney | Oxfordshire | OX26 6JS | United Kingdom |
|
| The House Partnership | Recruiting | Redhill | Surrey | RH1 1EB | United Kingdom |
|
| Swansea Bay University Health Board | Not yet recruiting | Baglan | Swansea | SA12 7BR | United Kingdom |
|
| University Hospitals of Liverpool Group | Recruiting | Liverpool | L9 7AL | United Kingdom |
|
| Moorfields Eye Hospital NHS Foundation Trust | Enrolling by invitation | London | United Kingdom |
| The Manor Group | Recruiting | Oxford | OX3 9BP | United Kingdom |
|
| Hedena Health | Recruiting | Oxford | OX3 9JA | United Kingdom |
|
| St Bartholomew and Hollow Way Medical Practice | Recruiting | Oxford | OX4 1XB | United Kingdom |
|
| Oxford Community Diagnostic centre | Recruiting | Oxford | OX42LL | United Kingdom |
|