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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT06119204
Eligibility Criteria:
Inclusion Criteria:
* Registered with a GP practice within the confirmed NHS site - Humber and North Yorkshire
* Diagnosis of type 2 diabetes treated with insulin
* Age 18-70 years inclusive
* BMI ≥30kg/m² (adjusted to ≥27 kg/m² in ethnic minority groups)
* Upper body weight limit of 180kg (if using BodyTrace scales)
* Ability to speak, read and receive care in English language
* Access to the internet and a personal email address
* Access to and ability to use a smartphone
* Willing to test blood glucose up to 7 times a day (for up to 4 months) to ensure clinical safety.
* Participants capable to provide written informed consent and willing to comply with the trial protocol
Exclusion Criteria:
* C-peptide \<200 pmol/L AND positive Glutamic Acid Decarboxylase(GAD) antibodies assessing for misdiagnosed Type 1 diabetes and risk of diabetic ketoacidosis.
* Type 1 diabetes mellitus, Mitochondrial diabetes, Maturity-Onset Diabetes of the Young (MODY) diabetes or diagnostic uncertainty (e.g. dual codes on patient record) Type 2 diabetes with history of diabetic ketoacidosis (DKA) or ketosis prone
* Clinically assessed hypoglycemia unawareness (via GOLD score (11, 12))
* Concomitant medication use clinically deemed to affect metabolic rate and body weight
* A major cardiovascular event within 6 months
* Severe angina, uncontrolled arrhythmia or known prolonged QT syndrome
* Warfarin or Rivaroxoban therapy
* Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m²
* A condition precipitating fluid overload (e.g. New York Heart Association class III-IV congestive heart failure)
* Active liver disease (except non-alcoholic fatty liver disease (NAFLD)
* Active gallstone disease or known presence of gallstones
* Active cancer, receiving cancer treatment or received cancer treatment within past 24 months
* Known proliferative retinopathy that has not been treated
* Uncontrolled epilepsy
* Uncontrolled thyroid dysfunction
* Active or suspected peptic ulcer disease
* Gout
* History of bariatric surgery (previous band/balloon allowed if removed\<12 months)
* Clinically diagnosed with an active eating disorder
* Clinically significant diagnosed/self-reported psychiatric disease that may interfere with study compliance
* Known or suspected alcohol or recreational drug misuse
* Milk allergy (Nualtra, TDR allergens)
* Soya allergy (Nualtra, TDR allergens)
* Vegan (Nualtra, animal derived Vit D)
* Pregnancy or planning pregnancy within study period
* Lactating
* Currently on a weight management programme or had in last 3 months or had over 5% weight loss in previous 6 months
* Current participation in other clinical intervention trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06119204
Study Brief:
Protocol Section:
NCT06119204