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

NCT05744232 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-07-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-03-01
Completion
2025-09-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05744232 on ClinicalTrials.gov