Type2 Diabetes
Conditions
Brief 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 5 years, in adult patients with type 2 diabetes lacking history of cardiovascular disease.
Detailed description
This will be a multi-site study adopting a prospective, observational cohort study design. There will be no intervention to the standard of care. Study participants will be enrolled in this study for a total of 5 years, with only 1 month of active participation. Participants will be required to attend a screening visit and 2 study visits. The screening visit will involve a medical review and receiving informed consent based on the participant information leaflet already communicated to the patient, pre-screening. The first study visit- baseline (visit 1) - will involve anthropometric measurements and taking a blood and urine sample in order to perform standard of care measurements for type 2 diabetes at baseline and relevant circulating biomarkers. The second study visit will involve having a multi-organ, multiparametric MRI scan. Both visits will be within 28 days of the screening visit and carried out at local study sites. MRI metrics of organ health, clinical outcome measurements, blood samples and urine samples will be collected to assess the natural history of diabetes disease progression. Participants will be asked to give consent for access to their medical records held at NHS England and, if available, at their local GP surgery or hospital. Medical records access will include Hospital admissions (Hospital Episode Statistics), and mortality data collected by the Office for National Statistics and provided by NHS England to meet the primary objective. This data will be collected at 1, 3 and 5 years after baseline assessment.
Interventions
OTHERMRI
MRI is not part of Pathway for patient with type two diabetes.
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Perspectum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 1 year from baseline | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes |
| 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) | 1 year from baseline | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations | 1 year from baseline | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality | 1 year from baseline | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes |
| 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 | 1 year from baseline | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension) | 1 year from baseline | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes |
| The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer | 1 year from baseline | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes |
| 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 | 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 |
| 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 | 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 |
| 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) | 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 |
| 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) | 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 |
| 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) | 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 |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations | 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 |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality | 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 |
| 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 | 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 |
| 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) | 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 |
| Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer | 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 |
| 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) | 1 year from baseline | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes |
| 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). | 1 year from baseline | The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes |
| 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) | 1 year from baseline | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes |
| 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) | 1 year from baseline | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations | 1 year from baseline | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality | 1 year from baseline | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes |
| 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 | 1 year from baseline | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes |
| 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 | 1 year from baseline | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes |
| The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer | 1 year from baseline | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes |
| 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) | 1 year from baseline | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes |
| 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) | 1 year from baseline | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes |
| 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) | 1 year from baseline | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes |
| 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) | 1 year from baseline | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes |
| 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 | 1 year from baseline | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes |
| 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 | 1 year from baseline | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes |
| 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 | 1 year from baseline | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes |
| 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 | 1 year from baseline | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes |
| 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 | 1 year from baseline | The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes |
| 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) | 1 year from baseline | The co-prevalence of diabetic retinopathy (DR) and metabolic dysfunction-associated steatotic liver disease (MASLD), using multi-parametric abdominal MRI |
| Correlations between liver MRI metrics (organ volume, fat infiltration and fibroinflammation) and eye metrics (retinal layer thickness by OCT, discrete retinopathy scores) | 1 year from baseline | The correlation between severity of eye disease and MRI-derived metrics of liver disease using multiparametric MRI |
| 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) | 1 year from baseline | The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes |
Countries
United Kingdom
Contacts
Primary ContactSoubera Rymall, MSc
Outcome results
None listed