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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT05744232
• Lead Sponsor: University of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-1-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Inclusion Criteria:<br><br> - Willing and able to give informed consent, can communicate in English<br><br> - Age between 18 and 65 years inclusive<br><br> - Live in England<br><br> - BMI =27 kg/m2 or higher (adjusted to =25 kg/m2 for people of Black, Asian and<br> minority ethnic origin)<br><br> - Diagnosed with T2D within 6 years prior to the day of screening<br><br> - Global EDE-Q scores =2.67<br><br> - To have an HbA1c taken in the last 12 months<br><br> - Latest HbA1c =43 mmol/mol (6.1%) and =87 mmol/mol (10%) if on diabetes medication OR<br> latest hbA1c = 48 mmol/mol (6.5%) and =87 mmol/mol (10%), if not on diabetes<br> medication.<br><br> - If diagnosed with type 2 diabetes more than 1 year since day of screening, the<br> participant must have attended their GP surgery for monitoring/ diabetes review when<br> last offered<br><br> - Commit to continue annual reviews with their GP, even if T2D remission is achieved<br><br>Exclusion Criteria:<br><br>The participant must not enter the study if ANY of the following apply:<br><br> - Current or previous clinical diagnosis of an eating disorder<br><br> - Combination of EDE-Q =4 AND a CIA score =16 at screening<br><br> - Currently participating in a structured weight loss programme or self-reporting that<br> they have lost >10% of their body weight in the last 3 months<br><br> - Insulin use<br><br> - Known kidney disease of stage 3/4/5 or eGFR <60 mls/min/1.73 m2 within the last 12<br> months<br><br> - Active substance use disorder<br><br> - Active cancer other than skin cancer<br><br> - Known proliferative retinopathy that has not been treated<br><br> - Porphyria<br><br> - Undergone or is awaiting bariatric surgery<br><br> - Myocardial infarction or stroke within previous 6 months<br><br> - Severe heart failure defined as equivalent to the New York Heart Association (NYHA)<br> grade 3 or 4<br><br> - Active liver disease (not including non-alcoholic fatty liver disease)<br><br> - Pregnant, breastfeeding, or planning to become pregnant during the course of the<br> study<br><br> - Soy or milk or fish allergy, lactose intolerance, or following a vegan diet<br><br> - People currently participating in another study or clinical trial of a<br> CTIMP/non-CTIMP

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global score of disordered eating psychopathology

Secondary Outcome Measures

Name	Time	Method
Global score of disordered eating psychopathology;Subscales of disordered eating psychopathology;Psychosocial impairment;Weight