UK Imaging Diabetes Study Seeing Diabetes Clearly
ConditionType2 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPerspectum
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
myocardial infarction
ischaemic stroke
hospital admission/discharge for unstable angina
heart surgery
Trial population
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. 1. Diabetes referral appointments 2. Diabetic retinopathy referral appointments 3. Primary care and diabetes clinics - including GP practices 4. Participant Identification Centres 5. Diabetes Eye Screening Programmes (DESP)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI
Other interventionMRI is not part of Pathway for patient with type two diabetes.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Type 2 diabetes1 intervention
Trial outcomes
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.
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.
Time frame
3 year from baselineSecondary 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).
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Time frame
1 year from baseline2
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
Time frame
3 years from baseline3
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
Time frame
5 years from baseline4
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
Time frame
1 year from baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Perspectum
Lead sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov