NCT05744232

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

The Impact of Low-energy totAl Diet Replacement With Behavioural Support for remIssion of Type 2 DIAbetes on disordEred eatiNg: the ARIADNE Randomised Non-inferiority Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The NHS has started a trial-run of a weight loss programme replacing food with 800-calorie shakes and soups for 3 months, offered to people with newly diagnosed type 2 diabetes (T2D) to lose weight and put their diabetes into remission. Some healthcare professionals and charities are sceptical about the programme's effect on people's mental health. They fear it may trigger people to have a negative relationship with food (disordered eating). Some studies show indirectly that these programmes are somewhat safe; however it is not known for sure if it could affect people's relationship with food for the worse. Investigators will invite 56 people with T2D and disordered eating (picked up by questionnaires they will fill in) to participate in a trial. Of these participants, 28 will get TDR and the rest will get their standard care. Investigators will then measure how their scores of disordered eating change at 1, 3, 4, 6, 12 and 24 months. Investigators also plan to analyse the recorded sessions to better understand participants' experiences using TDR and their thoughts about eating and body image. This study will help shed light on how safe this type of diet is for people with disordered eating. It may lead to screening for eating disorders if TDR becomes standard care. If concerns are unfounded, it can reassure people with type 2 diabetes and healthcare professionals.

Conditions

• Type2diabetes
• Disordered Eating
• Obesity
• Overweight and Obesity
• Diet Habit

Interventions

Type	Name	Description
BEHAVIORAL	Low calorie total diet replacement	Summary 1. Weeks 1-12: TDR phase 2. Weeks 13-14: Food reintroduction phase I 3. Weeks 15-16: Food reintroduction phase II 4. Weeks 17 till 20: Food reintroduction phase III 5. Weeks 21 till 24: Maintenance phase
OTHER	Usual care	Participants allocated to the control group will be offered and continue benefiting from standard care. Participants will not be stopped from pursuing any behavioural weight management programme but if they do, this will be recorded.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-03-01
• Completion: 2025-09-01
• First posted: 2023-02-24
• Last updated: 2025-07-08

Locations

1 site across 1 country: United Kingdom