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NCT Number: NCT05057403

UK Imaging Diabetes Study Seeing Diabetes Clearly

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.

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Key information

Conditions

Type2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Woodlands Medical Centre, Didcot, Oxfordshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

MRI is not part of Pathway for patient with type two diabetes.

Primary outcomes

  1. 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.

    Time frame: 3 year from baseline

    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.

Secondary outcomes

  1. 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 impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  2. 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 impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  3. 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 impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  4. 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 impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  5. 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 impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  6. 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 impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  7. 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 impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  8. 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 impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  9. 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 impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  10. 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 impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  11. 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 impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  12. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations

    Time frame: 5 years from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  13. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality

    Time frame: 1 year from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  14. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality

    Time frame: 3 years from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  15. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality

    Time frame: 5 years from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  16. 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

    Time frame: 1 year from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  17. 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

    Time frame: 3 years from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  18. 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

    Time frame: 5 years from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  19. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)

    Time frame: 1 year from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  20. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)

    Time frame: 3 years from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  21. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)

    Time frame: 5 years from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  22. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer

    Time frame: 1 year from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  23. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer

    Time frame: 3 years from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  24. The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer

    Time frame: 5 years from baseline

    The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes

  25. 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

    Time frame: 1 year from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  26. 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

    Time frame: 3 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  27. 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

    Time frame: 5 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  28. 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)

    Time frame: 1 year from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  29. 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)

    Time frame: 3 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  30. 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)

    Time frame: 5 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  31. 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)

    Time frame: 1 year from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  32. 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)

    Time frame: 3 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  33. 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)

    Time frame: 5 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  34. 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)

    Time frame: 1 year from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  35. 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)

    Time frame: 3 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  36. 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)

    Time frame: 5 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  37. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations

    Time frame: 1 year from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  38. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations

    Time frame: 3 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  39. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations

    Time frame: 5 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  40. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality

    Time frame: 1 year from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  41. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality

    Time frame: 3 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  42. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality

    Time frame: 5 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  43. 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

    Time frame: 1 year from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  44. 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

    Time frame: 3 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  45. 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

    Time frame: 5 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  46. 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)

    Time frame: 1 year from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  47. 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)

    Time frame: 3 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  48. 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)

    Time frame: 5 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  49. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer

    Time frame: 1 year from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  50. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer

    Time frame: 3 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  51. Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer

    Time frame: 5 years from baseline

    The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI

  52. 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)

    Time frame: 1 year from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  53. 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)

    Time frame: 3 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  54. 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)

    Time frame: 5 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  55. 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)

    Time frame: 1 year from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  56. 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)

    Time frame: 3 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  57. 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)

    Time frame: 5 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  58. 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)

    Time frame: 1 year from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  59. 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)

    Time frame: 3 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  60. 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)

    Time frame: 5 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  61. 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)

    Time frame: 1 year from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  62. 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)

    Time frame: 3 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  63. 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)

    Time frame: 5 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  64. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations

    Time frame: 1 year from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  65. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations

    Time frame: 3 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  66. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations

    Time frame: 5 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  67. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality

    Time frame: 1 year from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  68. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality

    Time frame: 3 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  69. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality

    Time frame: 5 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  70. 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

    Time frame: 1 year from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  71. 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

    Time frame: 3 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  72. 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

    Time frame: 5 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  73. 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

    Time frame: 1 year from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  74. 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

    Time frame: 3 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  75. 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

    Time frame: 5 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  76. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer

    Time frame: 1 year from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  77. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer

    Time frame: 3 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  78. The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer

    Time frame: 5 years from baseline

    The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes

  79. 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)

    Time frame: 1 year from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  80. 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)

    Time frame: 3 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  81. 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)

    Time frame: 5 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  82. 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)

    Time frame: 1 year from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  83. 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)

    Time frame: 3 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  84. 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)

    Time frame: 5 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  85. 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)

    Time frame: 1 year from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  86. 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)

    Time frame: 3 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  87. 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)

    Time frame: 5 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  88. 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)

    Time frame: 1 year from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  89. 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)

    Time frame: 3 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  90. 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)

    Time frame: 5 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  91. 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

    Time frame: 1 year from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  92. 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

    Time frame: 3 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  93. 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

    Time frame: 5 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  94. 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

    Time frame: 1 year from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  95. 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

    Time frame: 3 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  96. 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

    Time frame: 5 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  97. 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

    Time frame: 1 year from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  98. 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

    Time frame: 3 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  99. 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

    Time frame: 5 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  100. 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

    Time frame: 1 year from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  101. 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

    Time frame: 3 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  102. 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

    Time frame: 5 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  103. 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

    Time frame: 1 year from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  104. 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

    Time frame: 3 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  105. 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

    Time frame: 5 years from baseline

    The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes

  106. 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)

    Time frame: 1 year from baseline

    The co-prevalence of diabetic retinopathy (DR) and metabolic dysfunction-associated steatotic liver disease (MASLD), using multi-parametric abdominal MRI

  107. Correlations between liver MRI metrics (organ volume, fat infiltration and fibroinflammation) and eye metrics (retinal layer thickness by OCT, discrete retinopathy scores)

    Time frame: 1 year from baseline

    The correlation between severity of eye disease and MRI-derived metrics of liver disease using multiparametric MRI

Study contacts

Contact information is provided by the study sponsor or research team.

Soubera Rymall, MSc

CONTACT

[email protected]

00447919272482

Sponsors and collaborators

Lead sponsor

Perspectum

Industry

Collaborators

  • Moorfields Eye Hospital NHS Foundation Trust

Registry information

Acronym: UKIDS

Important dates

Study start
2022
Primary completion
2034
Study completion
2034
First posted
Sep 27, 2021
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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