UK Imaging Diabetes Study Seeing Diabetes Clearly

NCT05057403 | Recruiting

• 1 other identifier: 20/WM/0007
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 12

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.

Conditions

Type2 Diabetes

Outcome Measures

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.

  3 year from baseline

Secondary Outcomes (107)

• 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 effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).

  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).

  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)

  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)

  3 years from baseline

Study Arms (1)

Type 2 diabetes

Patients with type 2 diabetes, especially individuals who have been diagnosed in the last three years

Other: MRI

Interventions

MRI OTHER

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

Type 2 diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Perspectum: lead
• Moorfields Eye Hospital NHS Foundation Trust: collaborator

Study Sites (12)

Woodlands Medical Centre

Didcot, Oxfordshire, OX11 0BB, United Kingdom

RECRUITING

Eynsham Medical Centre

Eynsham, Oxfordshire, OX29 4QB, United Kingdom

RECRUITING

White Horse Medical Practice

Farringdon, Oxfordshire, SN7 7YU, United Kingdom

RECRUITING

Windrush Medical Practice

Witney, Oxfordshire, OX26 6JS, United Kingdom

RECRUITING

The House Partnership

Redhill, Surrey, RH1 1EB, United Kingdom

RECRUITING

Swansea Bay University Health Board

Baglan, Swansea, SA12 7BR, United Kingdom

NOT YET RECRUITING

University Hospitals of Liverpool Group

Liverpool, L9 7AL, United Kingdom

RECRUITING

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

ENROLLING BY INVITATION

The Manor Group

Oxford, OX3 9BP, United Kingdom

RECRUITING

Hedena Health

Oxford, OX3 9JA, United Kingdom

RECRUITING

St Bartholomew and Hollow Way Medical Practice

Oxford, OX4 1XB, United Kingdom

RECRUITING

Oxford Community Diagnostic centre

Oxford, OX42LL, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, white blood cells

Study Officials

• Ravi Pattanshetty

  Perspectum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soubera Rymall, MSc

CONTACT

00447919272482; soubera.rymell@perspectum.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 27, 2021
• Study Start: May 30, 2022
• Primary Completion (Estimated): June 1, 2034
• Study Completion (Estimated): June 1, 2034
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (12)