Ireland
--:--IST
Active, not recruiting Observational

Longitudinal Assessment of Multiple Organs in Patients With Type 2 Diabetes

NCT04114682 · tracked via the Priya Life Science UK tracker
Sponsor
Phase
Observational
Started
2020-01-27
Last updated
2025-12-01

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

Multi parametric MRI scan

Multi parametric MRI scan: There will be no intervention to the standard of care these patients receive. However, consented participants will be asked to make two study visits where a multiparametric MRI scan will be performed - these visits will be defined as visit 2 and visit 3. An optional echocardiogram may be included at Visit 2.

Study summary

MODIFY study is a multi-centre prospective, longitudinal, observational cohort study which aims to recruit 150 adult patients with type 2 diabetes recruited from community, primary care or secondary care settings. The total length of the study is 75 months. The aim of the study is to develop an MRI-based method to identify whom amongst people with Type 2 diabetes are at risk of further complications in their kidney, liver and cardiovascular system.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female over 18 years of age and diagnosed with type 2 diabetes. * Participant currently taking glucose lowering therapy. * Participant willing and able to give informed consent for participation in the study. Exclusion Criteria: * 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, haemoglobinopathies or significant structural renal tract abnormality. * Patients with known excessive alcohol intake. * 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.

Primary outcome measure(s)

  • Magnetic Resonance Imaging metrics for liver fibro-inflammation in patients with type 2 diabetes — 1 year
    In order to determine the degree of liver fibro-inflammation in this cohort of patients with type 2 diabetes multi-parametric abdominal MRI will be performed. the measurements following the Multi parametric MRI in the type 2 diabetic patients will be compared with the same type of measurements in healthy individuals

Trial sites (4)

FacilityCityRegionStatus
Aintree University Hospital NHS Foundation Trust Liverpool Merseyside
Oxford University Hospitals NHS Foundation Trust Oxford Oxfordshire
Perspectum Ltd. Oxford Oxfordshire
Royal Free Hospital NHS Foundation Trust London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04114682 on ClinicalTrials.gov ↗ ← All trials in the UK