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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT04653532
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with T2D within the previous 5-24 months
* Male or Female
* Aged 40-75
* Treat diabetes with only Metformin or lifestyle modifications (diet and exercise)
* For those prescribed Metformin: have used a stable dose for 3-months or more
Exclusion Criteria:
* Aged under 40 or over 75
* Glycated hemoglobin level (HbA1c) more than 10% (\>86mmol/mol)
* Blood pressure higher than 160/110 mmHg
* Treat diabetes with an antidiabetic drug other than Metformin (Sulfonylureas, Thiazolidinedione, dipeptidylpeptidase-4 inhibitors, sodium glucose co-transporter 2 inhibitors, glucagon-like peptide-1 receptor agonist, Acarbose, meglitinides)
* Prescription of Insulin
* Unstable angina (frequent chest pain)
* Myocardial infarction (heart attack) within the previous 3 months
* Transient ischemic attack (TIA) within the previous 6 months
* Heart failure ≥class 2
* Arrhythmia
* Inability to increase activity
* Pregnancy or planning to become pregnant
* Less than 6 months post childbirth or stopped breastfeeding less than 1 month ago
* Not owning a smartphone/ or having no data plan or access to WiFi
* currently meeting the recommended exercise guidelines (150 min of moderate intensity exercise per week).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT04653532
Study Brief:
Protocol Section:
NCT04653532