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

University of Oxford

Status: Active, not recruiting

Conditions: Type2diabetes; Diet Habit; Overweight and Obesity; Obesity; Disordered Eating

Treatments: Behavioral: Low calorie total diet replacement; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT05744232

R82152/RE001

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Intervention- Low calorie diet/ Total diet replacement

Experimental group

Description:

Participants 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).

Treatment:

Behavioral: Low calorie total diet replacement

Control- usual care

Other group

Description:

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. 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.

Treatment:

Other: Usual care