Longitudinal Assessment of Multiple Organs in Patients With Type 2 Diabetes

NCT04114682 | Active Not Recruiting DMC

• 1 other identifier: CA064
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; NAFLD; Metformin; Multiparametric MRI

Outcome Measures

Primary Outcomes (1)

• Magnetic Resonance Imaging metrics for liver fibro-inflammation in patients with type 2 diabetes

  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

  1 year

Secondary Outcomes (6)

• Correlation between Magnetic Resonance Imaging metrics for liver Fat infiltration and volume in patients with type 2 diabetes vs healthy people.

  1 year

• Correlation between Magnetic Resonance Imaging metrics for Pancreas, spleen, kidney and aorta indicating co-morbidities in patients with type 2 diabetes vs healthy people.

  1 year

• Detecting change in liver, spleen, pancreas and kidney using Magnetic Resonance Imaging metrics from baseline to 9 months

  9 months

• Detecting change in liver, spleen, pancreas and kidney using conventional biochemical biomarkers from baseline to 9 months

  9 months

• Impact of Multi parametric abdominal MRI on management of patients with type 2 diabetes

  1 year

Interventions

Multi parametric MRI scan OTHER

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.

Also known as: Optional echocardiogram

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 and over, with type 2 diabetes and prescribed with glucose lowering therapy as per their standard of care.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Perspectum: lead
• University of Liverpool: collaborator
• Liverpool University Hospitals NHS Foundation Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (4)

Aintree University Hospital NHS Foundation Trust

Liverpool, Merseyside, L9 7AL, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Perspectum Ltd.

Oxford, Oxfordshire, OX4 2LL, United Kingdom

Location

Royal Free Hospital NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Routine bloods will be performed as per standard-of-care for T2D; HbA1c, serum creatinine, electrolytes, lipids, FBC (full blood count), LFT (liver function tests (aspartate transaminase and alanine transaminase) and gamma glutamyl transferase (GGT) and eGFR. Additional circulating biomarkers, ie; the enhanced liver fibrosis test (ELF), N-terminal levels of type III procollagen (P3NP), pancreatic lipase, cystatin C, serum albumin, high sensitivity C-reactive protein, NT-proBNP and uric acid. Optional genetic testing for NAFLD or T2D associated genetic variants (serum sample).

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Dan Cuthbertson

  Liverpool hospitals

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: January 27, 2020
• Primary Completion: March 31, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

GB (4)