RecruitingInterventional

Pancreas lipotoxicity in type 2 diabetes: Edinburgh Diabetes Remission Study (EDRS)

The Edinburgh Diabetes Remission Study (EDRS) is investigating why some people get type 2 diabetes and if losing weight can help reverse it. Researchers believe that too much fat in the pancreas might play a role in developing the condition. The study will explore how the body creates and moves fat, and how this impacts the pancreas and its ability to produce insulin. Participants will follow an 8-12 week low-calorie diet using special meal replacements, followed by support to keep the weight off for up to a year. The study includes people with and without type 2 diabetes, ranging from those with pre-diabetes to those who have had diabetes for many years. It aims to understand the changes that lead to diabetes and its remission.

At a glance

Status

Recruiting

Enrolment target

104

Start

12 Jan 2026

Estimated completion

01 Jun 2028

Type 2 diabetes

What is this study about?

The Edinburgh Diabetes Remission Study, or EDRS, is looking into an important question: why do some people develop type 2 diabetes, and can we reverse it through weight loss? Scientists think that having too much fat in the pancreas – an organ crucial for producing insulin – might be a key reason. When there's too much fat, the pancreas might not work as well as it should, leading to problems with blood sugar control.

Previous research has shown that losing weight can sometimes put type 2 diabetes into remission, meaning blood sugar levels return to normal without medication. However, we don't fully understand *how* this happens. This study aims to find out more about how the body makes fat, how fat travels in the blood, and how these processes affect the pancreas and insulin production. By studying different groups of people – from those who don't have diabetes, to those with early signs (pre-diabetes), and those who have had type 2 diabetes for a short or long time – researchers hope to uncover the step-by-step changes that lead to diabetes and its remission.

All participants in the study will follow a special low-calorie diet for a period of time. This diet uses meal replacements and provides about 800 calories per day, which is designed to help with weight loss. After this initial diet period, participants will receive support to help them maintain their new weight. This will allow the researchers to observe the effects of weight loss on the pancreas, liver, and overall body, helping us learn more about preventing and managing type 2 diabetes.

Key takeaways

The study explores how fat in the pancreas causes type 2 diabetes and if weight loss can reverse it.
Participants follow an 8-12 week low-calorie diet using meal replacements.
The study includes people with no diabetes, pre-diabetes, and type 2 diabetes.
Benefits might include weight loss and improved blood sugar, possibly leading to diabetes remission.
Risks include hunger and need for careful medical monitoring, especially for medication changes.
The study is taking place in Edinburgh, UK, from 2026 to 2028.

Who may be eligible?

This study is looking for adults aged between 45 and 79 years old who have a body mass index (BMI) between 30 and 45. They are interested in people from four different groups: those who do not have diabetes, those with 'pre-diabetes' (meaning their blood sugar levels are higher than normal but not yet full diabetes), and those who have been living with type 2 diabetes for either less than 6 years or more than 10 years.

To join, you must be able to understand the study information and give your consent, be able to communicate in English, and be willing to stick to the special diet and attend all the follow-up appointments. For women, only those who have gone through menopause can take part. This helps the researchers focus on the effects of the diet without hormonal changes affecting the results.

There are also some reasons why you might not be able to join. For example, if you are currently taking insulin for your diabetes, if your blood sugar levels are extremely high, or if you've lost a lot of weight recently (more than 5kg in the last 6 months). You also can't take part if you've had a heart attack recently, have certain medical conditions like advanced kidney or liver disease, or if you're taking certain medications like steroids. People who can't have an MRI scan (for example, due to metal implants) also won't be able to participate.

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 aged between 45 and 79 years old?
Do you have a BMI between 30 and 45?
Are you able to speak and understand English well?
Are you willing to follow a special diet and attend study appointments?
If you are a woman, have you gone through menopause?
Are you NOT currently using insulin for your diabetes?

Answer every question to see your result.

What does participation involve?

If you join this study, everyone will follow a low-calorie diet for about 8 to 12 weeks. This diet involves using special, commercially available meal replacements that provide around 800 calories per day. After this initial period, you'll receive support and guidance for up to 12 months to help you maintain any weight loss you've achieved.

Throughout the study, you'll have several assessments to help the researchers understand the changes happening in your body. These will include blood tests to check various levels, and MRI scans of your pancreas and liver to see how much fat is present. There will be other assessments too, which will be fully explained to you. Some participants may also have a small fat biopsy, which involves taking a tiny sample of fat for further analysis. Your medical team will monitor you closely to ensure your safety throughout the study.

Potential risks and benefits

Participating in this study might bring several benefits, such as losing weight and gaining better control over your blood sugar levels. For some people with type 2 diabetes, this could even lead to remission, where their diabetes symptoms improve significantly or disappear. However, there are also some potential risks. You might feel hungry, especially during the initial low-calorie diet phase. If you are taking medication for blood pressure or blood sugar, there could be changes that require careful monitoring and adjustment by the study team. Some of the tests, like MRI scans or a fat biopsy, might cause some discomfort. Your safety will be closely watched by the study team throughout your participation, and you are free to withdraw from the study at any time without giving a reason.

Locations (1)

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

Clinical Research Facility, Royal Infirmary of Edinburgh
City only
Edinburgh, Scotland

Common questions

What is 'lipotoxicity'?

It means damage to cells, like those in the pancreas, caused by too much fat. This study is looking at how this might relate to type 2 diabetes.

What is a 'Total Diet Replacement (TDR)' program?

It's a way of eating where you replace all your usual meals with specially formulated shakes, soups, or bars, to ensure you get all your nutrients while eating fewer calories.

What is 'diabetes remission'?

This is when someone with type 2 diabetes returns to normal blood sugar levels without needing to take diabetes medication.

Will I have to pay to join the study?

No, clinical trials usually cover the costs associated with your participation, such as diet products and tests.

Who is funding this research?

The study is funded by the Medical Research Council and is sponsored by ACCORD in the UK.

How to find out more

Mary Wright

edrs@ed.ac.uk +44 (0)1312426717 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.