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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05744232
• Other study ID #: R82152/RE001
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2023
• Source: University of Oxford
• Contact: Elena Tsompanaki, MSc
• Phone: + 44 (0)1865289669
• Email: elena.tsompanaki[@]phc.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diet Habit
• Disordered Eating
• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Low calorie total diet replacement
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

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.

Locations

Country	Name	City	State
United Kingdom	Nuffield Department of Primary Care Health Sciences	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in medication	Changes in diabetes medication between TDR and control	12, 24 and 52 weeks
Other	Changes in quality of life	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.	12, 24 and 52 weeks
Other	Process evaluation of significant changes in disorder eating psychopathology during the intervention	Qualitative analysis of transcribed sessions with the dietitian in people with significant EDE-Q changes (more than 1 SD)	Through study completion, an average of 1 year
Other	Safety/ New cases needing referral to specialist services	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	Through study completion, an average of 1 year
Primary	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.	24 weeks
Secondary	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.	4, 12, 16, and 52 weeks
Secondary	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.	4, 12, 16, 24 and 52 weeks
Secondary	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.	4, 12, 16, 24 and 52 weeks
Secondary	Weight	Changes between group, assessed by self-weighing	12, 24 and 52 weeks