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NCT Number: NCT05744232

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Type2diabetes Behavior Behavior, Animal Body Weight Diet Habit Disordered Eating Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nuffield Department of Primary Care Health Sciences

Oxford, OX26GG, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to give informed consent, can communicate in English
  • Age between 18 and 65 years inclusive
  • Live in England
  • BMI ≥27 kg/m2 or higher (adjusted to ≥25 kg/m2 for people of Black, Asian and minority ethnic origin)
  • Diagnosed with T2D within 6 years prior to the day of screening
  • Global EDE-Q scores ≥2.67
  • To have an HbA1c taken in the last 12 months
  • Latest HbA1c ≥43 mmol/mol (6.1%) and ≤87 mmol/mol (10%) if on diabetes medication OR latest hbA1c ≥ 48 mmol/mol (6.5%) and ≤87 mmol/mol (10%), if not on diabetes medication.
  • If diagnosed with type 2 diabetes more than 1 year since day of screening, the participant must have attended their GP surgery for monitoring/ diabetes review when last offered
  • Commit to continue annual reviews with their GP, even if T2D remission is achieved

Exclusion criteria

The participant must not enter the study if ANY of the following apply:

  • Current or previous clinical diagnosis of an eating disorder
  • Combination of EDE-Q ≥4 AND a CIA score ≥16 at screening
  • Currently participating in a structured weight loss programme or self-reporting that they have lost >10% of their body weight in the last 3 months
  • Insulin use
  • Known kidney disease of stage 3/4/5 or eGFR <60 mls/min/1.73 m2 within the last 12 months
  • Active substance use disorder
  • Active cancer other than skin cancer
  • Known proliferative retinopathy that has not been treated
  • Porphyria
  • Undergone or is awaiting bariatric surgery
  • Myocardial infarction or stroke within previous 6 months
  • Severe heart failure defined as equivalent to the New York Heart Association (NYHA) grade 3 or 4
  • Active liver disease (not including non-alcoholic fatty liver disease)
  • Pregnant, breastfeeding, or planning to become pregnant during the course of the study
  • Soy or milk or fish allergy, lactose intolerance, or following a vegan diet
  • People currently participating in another study or clinical trial of a CTIMP/non-CTIMP

Treatment and study plan

Low calorie total diet replacement

Behavioral

Summary

  • Weeks 1-12: TDR phase
  • Weeks 13-14: Food reintroduction phase I
  • Weeks 15-16: Food reintroduction phase II
  • Weeks 17 till 20: Food reintroduction phase III
  • Weeks 21 till 24: Maintenance phase

Usual Care

Other

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.

Primary outcomes

  1. Global score of disordered eating psychopathology

    Time frame: 24 weeks

    Between group difference in scores of disordered eating psychopathology, as measured by the global score of the self-administered Eating Disorders Examination questionnaire (EDE-Q). Scores range from 0 to 6, with higher scores indicating more severe eating disorders psychopathology.

Secondary outcomes

  1. Global score of disordered eating psychopathology

    Time frame: 4, 12, 16, 52 and 104 weeks

    Between group difference in scores of disordered eating psychopathology, as measured by the global score of the self-administered Eating Disorders Examination questionnaire (EDE-Q). Scores range from 0 to 6, with higher scores indicating more severe eating disorders psychopathology.

  2. Subscales of disordered eating psychopathology

    Time frame: 4, 12, 16, 24, 52 and 104 weeks

    Between group difference in sub-scale scores of disordered eating, assessed by the subscale scores of Eating Disorders Examination questionnaire (EDE-Q): Restraint, Eating concern, Shape concern, Weight concern. Subscale scores reflect the severity of the specific characteristics of disordered eating. Higher scores in each subgroup indicate more severe psychopathology.

  3. Psychosocial impairment

    Time frame: 4, 12, 16, 24, 52 and 104 weeks

    Between group difference in psychosocial impairment, assessed by the self-administered clinical impairment assessment (CIA) questionnaire. The CIA measures the severity of psychosocial impairment due to eating disorder features, and scores range from o to 48, with higher scores indicating more severe impairment.

  4. Weight

    Time frame: 4, 12, 16, 24, 52 and 104 weeks

    Changes between group, assessed by self-weighing

Other outcomes

  1. Changes in medication

    Time frame: 12, 24, 52 and 104 weeks

    Changes in diabetes medication between TDR and control

  2. Changes in quality of life

    Time frame: 12, 24, 52 and 104 weeks

    Between group difference in quality of life, measured by the Problem Areas In Diabetes (PAID) Scale. PAID is used to measure distress related to emotions, treatment, food and social support in living with diabetes. Scores range from 0 to 100, with higher scores indicating higher diabetes distress.

  3. Process evaluation of significant changes in disorder eating psychopathology during the intervention

    Time frame: Through study completion, an average of 2 years

    Qualitative analysis of transcribed sessions with the dietitian in people with significant EDE-Q changes (more than 1 SD)

  4. Safety/ New cases needing referral to specialist services

    Time frame: Through study completion, an average of 1 year

    To examine the safety signals of TDR in people with disordered eating, by collecting the incidence of cases of high suspicion of a new eating disorder, measured by referral of participant to see their GP for further referral to specialist services

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 24, 2023
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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