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 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT05648903
Eligibility Criteria:
Inclusion Criteria:
* Registered with one of the Nexus Group GP Practices
* Willing to give consent for participation including collection of clinical outcomes
* Diagnosis of type 2 diabetes
* Minimum age of 18 years
* Maximum age of 70 years
* Minimum BMI of 27kg/m² (adjusted to 25kg/m² in people of South Asian or Chinese origin)
* Upper weight limit of 180kg (due to upper weight limit of BodyTrace scales)
* HbA1c eligibility:
* If on diabetes medication, HbA1c ≥ 43 mmol/mol
* If on diet alone, HbA1c ≥ 48 mmol/mol
* HbA1c \<108mml/mol
* Ability to speak, read and receive care in English
* Access to internet and email address
Exclusion Criteria:
* Currently taking insulin
* Pregnant or planning to be pregnant in the next 6 months
* Current breastfeeding
* Significant physical comorbidities:
* Active cancer, receiving treatment
* Myocardial infarction or stroke in last 6 months
* Severe heart failure defined as equivalent to the New York heart Association grade 3 or 4 (NYHA)
* eGFR \<30 mls/min/1.73m2
* Active liver disease (except non-alcoholic fatty liver disease (NAFLD),Severe angina, cardiac arrhythmia including atrial fibrillation or prolonged QT syndrome
* Active substance use disorder
* Active eating disorder
* Porphyria
* On current weight management programme / had or awaiting bariatric surgery (unless willing to come off waiting list)
* Health professional assessment that the person is unable to understand or meet the demands of the programme and/or monitoring requirements
* Taking monoamine-oxidase inhibitor medication
* Taking warfarin
* Taking varenicline (smoking cessation medication)
* Have attended for monitoring and diabetes review when this was last offered, including retinal screening, and commit to continue attending reviews, even if remission is achieved
* Active/investigation for gastric or duodenal ulcers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05648903
Study Brief:
Protocol Section:
NCT05648903