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Type2diabetesNCT05744232

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

A study testing Low calorie total diet replacement in people with Type2diabetes and Disordered Eating, run by University of Oxford at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type2diabetes, Disordered Eating, Obesity
What is being tested?
Low calorie total diet replacement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited Kingdom
Study dates
1 Mar 2023to 1 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Nuffield Department of Primary Care Health Sciences

    Oxford, Oxford, OX26GG

Other trials in United Kingdom

About this study

Official 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

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.

Being tested
Low calorie total diet replacement, Usual care
Medical subject headings
Obesity, Overweight, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low calorie total diet replacementBehavioural

    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

  • Usual careOther

    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.

Study groups in NCT05744232
Study groupRoleWhat they receive
Intervention- Low calorie diet/ Total diet replacementExperimentalParticipants in the intervention group will be offered a dietitian-delivered intervention over 6 months, similar to the NHS pilot of low calorie diets for type 2 diabetes remission. The intervention starts with 12 weeks of low-energy total diet replacement (approx. 860 kcal/day) in a nutritionally replete package of soups, shakes, and bars. It continues with stepped food reintroduction (maximum 6 weeks) as a low-calorie, nutrient-rich diet personalised to the individual participant circumstances and preferences, and weight maintenance (6 weeks).
Receives: Behavioral: Low calorie total diet replacement
Control- usual careOtherParticipants 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. Participants will be offered an invitation to a 30-45' 1:1 session with the research dietitian at the end of the study to provide help and signposting as required for the management of their diabetes.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global score of disordered eating psychopathology

    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.

    Measured: 24 weeks

Secondary outcomes (4)

  1. Global score of disordered eating psychopathology

    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.

    Measured: 4, 12, 16, 52 and 104 weeks

  2. Subscales of disordered eating psychopathology

    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.

    Measured: 4, 12, 16, 24, 52 and 104 weeks

  3. Psychosocial impairment

    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.

    Measured: 4, 12, 16, 24, 52 and 104 weeks

  4. Weight

    Changes between group, assessed by self-weighing

    Measured: 4, 12, 16, 24, 52 and 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start1 Mar 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05744232
Sponsor's protocol ID
R82152/RE004
Status last verified
Aug 2024
First submitted
25 Jan 2023
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Tsompanaki E, Aveyard P, Park RJ, Jebb SA, Koutoukidis DA. An intensive weight loss programme with behavioural support for people with type 2 diabetes at risk of eating disorders in England (ARIADNE): a randomised, controlled, non-inferiority trial. Lancet Psychiatry. 2025 Jul;12(7):483-492. doi: 10.1016/S2215-0366(25)00126-9.

    PubMed 40506207

  • Tsompanaki E, Aveyard P, Park RJ, Koutoukidis DA. The impact of low-energy total diet replacement with behavioural support for remission of type 2 diabetes on disordered eating (ARIADNE): Protocol for a non-inferiority randomised controlled trial. Contemp Clin Trials. 2024 Jul;142:107542. doi: 10.1016/j.cct.2024.107542. Epub 2024 Apr 27.

    PubMed 38685400

Questions about this trial

What is this clinical trial studying?

A study testing Low calorie total diet replacement in people with Type2diabetes and Disordered Eating, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global score of disordered eating psychopathology (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05744232, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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