RecruitingNAINTERVENTIONAL

Pancreas Lipotoxicity in T2D: Edinburgh Diabetes Remission Study (EDRS)

This Edinburgh study, called EDRS, explores how fat accumulation within the pancreas contributes to type 2 diabetes and if weight loss can reverse this. We know weight loss can put diabetes into remission, but we need to understand the exact reasons why. Researchers will recruit people with and without diabetes, aged 45-79, who are overweight. All participants will follow an 8-12 week special diet (800 calories/day) to achieve weight loss, followed by support to keep it off. The study hopes to understand how the liver turns sugar into fat and how this affects the pancreas, leading to better ways to treat type 2 diabetes.

At a glance

Status

Recruiting

Phase

Sponsor

University of Edinburgh

Enrolment target

104

Start

30 Jan 2026

Estimated completion

31 Dec 2029

Type 2 Diabetes

What is this study about?

The Edinburgh Diabetes Remission Study (EDRS) is looking into a really important question: why does type 2 diabetes develop, and can we reverse it by losing weight? Previous research has hinted that losing weight can make type 2 diabetes go away for some people. This seems to be linked to reducing the amount of fat within the pancreas, a key organ for managing blood sugar. However, the exact steps and changes in the body that lead to this improvement are still not fully clear. This study aims to fill in those gaps, focusing on how the liver processes fats and how this affects the pancreas, particularly after someone has lost weight.

To understand these changes, the study will involve different groups of people: those who don't have diabetes, those who might be developing it (pre-diabetes), and those who have had type 2 diabetes for either a shorter period (less than 6 years) or a longer time (over 10 years). Everyone taking part will be aged between 45 and 79 and will be overweight. A core part of the study involves following a special, low-calorie diet for 8 to 12 weeks to help with weight loss, followed by a plan to maintain that loss. This approach will allow the research team to carefully observe how the body's fat storage and sugar-handling systems change. The study is run by NHS Lothian and the University of Edinburgh at the Royal Infirmary of Edinburgh, with a team of specialist nurses, doctors, and dietitians.

Ultimately, by carefully tracking changes in weight, blood sugar levels, and fat in organs like the liver and pancreas, the researchers hope to understand the detailed steps that lead to type 2 diabetes remission. This knowledge could be crucial. It might help doctors and scientists develop more effective and targeted treatments for type 2 diabetes in the future, offering new hope for many people.

Key takeaways

Aims to understand how weight loss can reverse type 2 diabetes.
Involves a structured low-calorie diet and ongoing support.
Various groups of people, with and without diabetes, are needed.
Will track changes in body fat, blood sugar, and organ health.
Could lead to better diabetes treatments in the future.

Who may be eligible?

This study is looking for both men and women, aged between 45 and 79 years old, who are overweight or obese (with a BMI between 30 and 45). For women, you must have gone through menopause. You also need to be able to speak good English to understand the study information and dietary advice.

We are looking for four main groups of people: those who don't have diabetes, those who might be developing it (called pre-diabetes), and people with type 2 diabetes who have had it for either less than 6 years or more than 10 years. If you have type 2 diabetes, you should be managing it with diet alone or with tablets, but not with insulin.

There are some conditions that would mean you couldn't join. For example, if you are currently taking insulin for your diabetes, have had a heart attack recently, have certain serious health problems like advanced kidney or liver disease, or if you've lost a lot of weight unintentionally in the last six months. Also, if you have any metal implants that prevent you from having an MRI scan, or if you are currently in another clinical study, you wouldn't be able to take part.

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 between 45 and 79 years old?
Are you overweight (BMI 30-45)?
Are you a post-menopausal woman?
Do you speak and understand English well?
Are you NOT taking insulin for diabetes?
Do you NOT have metal that would stop an MRI scan?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first follow a special low-calorie diet for 8 to 12 weeks. This diet involves using special shakes and soups (called Total Diet Replacement) to help you lose weight. After this initial period, you'll receive ongoing support to help you keep the weight off for a longer period, possibly up to 6 to 12 months. Throughout the study, you'll have regular visits to the Clinical Research Facility at the Royal Infirmary of Edinburgh. These visits will involve various tests to check your progress and health. This could include measuring your weight, taking blood samples to check blood sugar and other markers, and having imaging scans like an MRI to look at your liver and pancreas. Some participants may also have small biopsies (tiny tissue samples) taken from fat, after a local anaesthetic. The specialist team, including a research nurse, doctor, and dietitian, will guide you through each step. The full duration of your participation, including follow-up, will be discussed with you, but the aim is to track changes for up to a year.

Potential risks and benefits

Participating in this study could offer several potential benefits. You would receive support to achieve significant weight loss, which might lead to your type 2 diabetes going into remission or improving your overall health if you have pre-diabetes or no diabetes. You'll also be closely monitored by a specialist healthcare team. However, as with any study, there are potential risks. The low-calorie diet might cause temporary side effects such as fatigue or headaches, and there are small risks associated with blood tests or MRI scans. If you have a biopsy, there's a minor risk of bruising or discomfort. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

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
Verified postcode
Edinburgh, United Kingdom· Recruiting

Common questions

What is 'remission' for type 2 diabetes?

Diabetes remission means your blood sugar levels are back to normal without needing diabetes medication, often achieved through significant weight loss.

What is a 'Total Diet Replacement'?

It's a special diet plan where you replace all your usual meals with nutritionally complete, low-calorie shakes and soups for a set period.

Will I need to take any new medication?

The study focuses on diet, not new medication. If you take diabetes tablets, you might be able to reduce or stop them if your diabetes improves with weight loss.

How long will I be in the study?

The initial diet part is 8-12 weeks, followed by support to keep weight off for up to 6-12 months. The total time for follow-up will be explained.

Where does the study take place?

The study is carried out at the Clinical Research Facility, Royal Infirmary of Edinburgh.

How to find out more

Study Team

edrs@ed.ac.uk +44(0)131 242 6717 Official trial record

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