Active not recruitingNAINTERVENTIONAL

ARIADNE: A Study of Weight Loss for Diabetes Treatment and Wellbeing

The NHS is testing a special diet for people with newly diagnosed type 2 diabetes where they replace meals with 800-calorie shakes and soups for three months. This study wants to understand if this diet is safe, particularly for people who might already have worries about their eating habits. Some health experts are concerned this diet could make food worries worse. We're looking for 56 people with type 2 diabetes who also have some concerns about their eating, identified through questionnaires. Half will follow the special diet, and the other half will receive their usual care. We will check how their eating habits and diabetes change over two years. This research will help us decide if this type of diet is a good and safe option for more people with type 2 diabetes in the future.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Oxford

Enrolment target

Start

01 Mar 2023

Estimated completion

01 Sep 2025

Type2diabetes Disordered Eating Obesity Overweight and Obesity Diet Habit

What is this study about?

The NHS has been trying out a special diet programme to help people with recently diagnosed type 2 diabetes. In this programme, people use special low-calorie shakes and soups instead of regular food for three months. The main goal is to help them lose weight and potentially put their diabetes into remission, meaning their blood sugar levels return to normal.

However, some doctors and charities are worried that this kind of strict diet might not be suitable for everyone. They are particularly concerned it could affect people's mental health or make them have a difficult relationship with food, sometimes called 'disordered eating'. While some earlier studies suggest these diets are generally safe, we don't know for sure if they could cause problems with how people view food and their bodies, especially if they already have some concerns in this area.

This study, called ARIADNE, aims to find out more. We are inviting 56 people who have type 2 diabetes and also show some signs of disordered eating (which we will check using questionnaires). We will split them into two groups: one group will follow the special diet, and the other will continue with their usual care from their doctor. By carefully watching both groups for two years, we hope to understand how their relationship with food changes, and if the diet helps with their diabetes. This research is really important because it will help us understand if this diet is safe for everyone and if we need to check people for eating concerns before they start such a programme.

Key takeaways

This study looks at a special diet for type 2 diabetes.
It checks if the diet is safe for people concerned about eating.
Half of the participants will use low-calorie shakes and soups.
The other half will get their usual diabetes care.
The study lasts two years to see long-term effects.
It helps us understand if this diet is a good option for more people.

Who may be eligible?

To be able to join this study, you need to be aged between 18 and 65 and live in England. You should have been diagnosed with type 2 diabetes within the last six years. Your body mass index (BMI) should generally be 27 or higher, although for people of Black, Asian, and other minority ethnic backgrounds, it can be 25 or higher. We also need to be able to talk with you in English and for you to agree to take part after understanding what is involved.

Certain things mean you can't join the study. For example, if you have a current or past official diagnosis of an eating disorder, or if you are currently using insulin for your diabetes. You also can't take part if you have certain serious health conditions like advanced kidney or liver disease, severe heart problems, or if you've recently had a heart attack or stroke. We also can't include you if you are pregnant, breastfeeding, planning to get pregnant, or have certain food allergies (like soy, milk, or fish), or if you follow a vegan diet due to the ingredients in the shakes and soups.

We also can't accept you if you're already in another research study, or if you've lost a lot of weight recently (more than 10% of your body weight in the last three months) from another structured weight loss programme.

Quick self-check

Are you between 18 and 65 years old?
Do you live in England?
Were you diagnosed with type 2 diabetes within the last 6 years?
Do you have a BMI of 27 or higher (or 25+ if you are of Black, Asian, or other minority ethnic backgrounds)?
Are you able to understand and agree to take part after hearing about the study?
Are you NOT pregnant, breastfeeding, or planning to get pregnant during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll be put into one of two groups by chance. One group will follow the special diet, which means replacing all your meals with 800-calorie shakes and soups for three months. The other group will receive their usual care for diabetes. During the study, you'll have several check-ups over two years, at 1, 3, 4, 6, 12, and 24 months. These visits will involve filling out questionnaires about your eating habits and wellbeing, and we'll also check your blood sugar levels. For some participants, we may also record conversations to understand your experiences with the diet and your thoughts on food and body image. The total duration of your active involvement in the study, including all follow-up appointments, will be 24 months.

Potential risks and benefits

Taking part in this study could potentially help you manage your type 2 diabetes, perhaps even putting it into remission, which would be a significant benefit. However, there's a possibility that the strict diet could affect your relationship with food or your mental health, which is what the study aims to understand better. You also might not see any direct benefits from participating. It's really important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Nuffield Department of Primary Care Health Sciences
Oxford, United Kingdom

Common questions

What is 'disordered eating'?

Disordered eating means having worries or difficult feelings about food, eating, or your body, which can affect your health and wellbeing.

What is 'total diet replacement'?

Total diet replacement means you replace all your regular meals with special low-calorie shakes and soups for a set period, like three months.

How long will the study last if I take part?

If you join the study, you will be followed for a total of two years, with several check-ups during that time.

Will I get help with the diet if I'm in that group?

Yes, if you are in the diet group, you will receive the shakes and soups and support to follow the programme.

What happens if my eating worries get worse?

If you have concerns about your eating habits at any point during the study, please let the study team know immediately so they can provide support and guidance.