Active not recruitingOBSERVATIONAL

Longitudinal Assessment of Multiple Organs in Patients With Type 2 Diabetes

The MODIFY study is looking for 150 adults with Type 2 diabetes across the UK. We want to understand how diabetes can affect important organs such as the kidneys, liver, and heart over time. Participants will have special MRI scans, which are a safe way to look inside the body without radiation. Our goal is to develop a new method using these scans to identify people with Type 2 diabetes who might be at higher risk of developing health problems linked to their diabetes. This research will help doctors better predict and hopefully prevent these complications, improving care for people with Type 2 diabetes in the future.

At a glance

Status

Active not recruiting

Sponsor

Perspectum

Enrolment target

135

Start

27 Jan 2020

Estimated completion

30 Sep 2026

Type 2 Diabetes

What is this study about?

Type 2 diabetes is a common condition where the body doesn't use insulin properly. While it can often be managed, over time it can affect many parts of the body, including vital organs like your kidneys, liver, and heart. Currently, doctors often rely on blood tests to check on these organs, but these tests don't always show the full picture of how diabetes might be affecting someone. For example, some people can have early signs of liver problems linked to diabetes that don't show up in standard blood tests.

This study, called MODIFY, wants to find a better way to spot these changes earlier. We're using a special type of scan called an MRI (Magnetic Resonance Imaging). Unlike X-rays, MRI uses strong magnets and radio waves to create detailed pictures of the inside of your body. This allows doctors to examine organs like your kidneys, liver, and heart very closely to see if diabetes is having an impact.

The main aim is to develop a new method using these MRI scans. This method would help doctors identify people with Type 2 diabetes who might be at higher risk of developing more serious complications in these organs. By understanding this sooner, healthcare professionals could potentially offer more tailored care, which could help prevent or better manage these complications, ultimately leading to better health for people with Type 2 diabetes.

Key takeaways

This study uses special scans to check how Type 2 diabetes affects kidneys, liver, and heart.
It aims to find new ways to identify people at risk of diabetes-related health problems.
Around 150 adults with Type 2 diabetes will be invited to take part across the UK.
Participation involves having MRI scans over several years, but no new medications.
The research helps improve understanding and future care for people with Type 2 diabetes.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) who has been diagnosed with Type 2 diabetes and is currently taking medication to help manage your blood sugar levels. It's also important that you are happy to provide your agreement to participate.

There are some reasons why you might not be able to join. For example, if you have any medical conditions that prevent you from having an MRI scan, such as a pacemaker, certain metal implants, or severe claustrophobia. You also can't be pregnant. The study also cannot include individuals with certain specific liver or kidney conditions, known excessive alcohol intake, or other serious health issues that the study doctors believe would make participation unsafe or affect the study results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Type 2 diabetes?
Are you currently taking medication for your diabetes?
Can you have an MRI scan (e.g., no pacemaker, certain metal implants, severe claustrophobia)?
Are you not pregnant?
Do you not have certain specific liver or kidney conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be part of the study for an extended period, which could be up to 75 months (roughly over 6 years). The main activity will involve having special MRI scans. These scans are a safe and non-invasive way to get detailed pictures of your internal organs like your kidneys, liver, and heart. You won't be given any new medications as part of this study; it's purely observational, meaning we're just looking at how your body responds to your existing diabetes management over time. The researchers will explain exactly how many visits you'll need and what each visit will involve.

Potential risks and benefits

A potential benefit of joining this study is contributing valuable information that could lead to better ways of detecting and preventing complications of Type 2 diabetes for others in the future. While there are no direct health benefits to you personally, your participation could help improve care for many people. The main 'risk' is the time commitment required for the study visits and MRI scans. MRI scans are generally very safe, but they do involve lying still in a confined space for a period. You will be fully informed about what an MRI involves before you decide. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Aintree University Hospital NHS Foundation Trust
Verified postcode
Liverpool, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Verified postcode
Oxford, United Kingdom
Perspectum Ltd.
Verified postcode
Oxford, United Kingdom
Royal Free Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is an MRI scan?

An MRI scan uses strong magnets and radio waves to create detailed pictures of the inside of your body. It doesn't use X-rays or radiation and is generally very safe.

How long will I be in the study?

The study runs for around 75 months, which is over 6 years. You'll have several visits for scans during this time.

Will I get new medication from this study?

No, this study is about observing how Type 2 diabetes affects your body over time, not about testing new medications. You will continue with your usual diabetes care.

Will my regular doctor be involved?

You will continue to receive your usual medical care from your own doctors. This study is additional research, and the researchers will talk to you about how information might be shared with your GP, with your permission.

What happens to the information from my scans?

The information from your scans will be used by the research team, in a confidential way, to understand how Type 2 diabetes affects organs. Your personal details will be kept private.