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 and 12 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.

Inclusion Criteria:Willing and able to give informed consent, can communicate in EnglishAge between 18 and 65 years inclusiveLive in EnglandBMI ≥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 screeningGlobal EDE-Q scores ≥2.67To have an HbA1c taken in the last 12 monthsLatest 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 offeredCommit to continue annual reviews with their GP, even if T2D remission is achievedExclusion Criteria:The participant must not enter the study if ANY of the following apply:Current or previous clinical diagnosis of an eating disorderCombination of EDE-Q ≥4 AND a CIA score ≥16 at screeningCurrently participating in a structured weight loss programme or self-reporting that they have lost >10% of their body weight in the last 3 monthsInsulin useKnown kidney disease of stage 3/4/5 or eGFR <60 mls/min/1.73 m2 within the last 12 monthsActive substance use disorderActive cancer other than skin cancerKnown proliferative retinopathy that has not been treatedPorphyriaUndergone or is awaiting bariatric surgeryMyocardial infarction or stroke within previous 6 monthsSevere heart failure defined as equivalent to the New York Heart Association (NYHA) grade 3 or 4Active liver disease (not including non-alcoholic fatty liver disease)Pregnant, breastfeeding, or planning to become pregnant during the course of the studySoy or milk or fish allergy, lactose intolerance, or following a vegan dietPeople currently participating in another study or clinical trial of a CTIMP/non-CTIMP