Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT05744232
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05744232
Study Brief:
Protocol Section:
NCT05744232