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:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT07017127
Eligibility Criteria:
Inclusion Criteria:
* type 2 diabetes diagnosis
* incident cases or diagnosed not more than 7 years ago
* body mass index of 27-45 kg/m²
Exclusion Criteria:
* mobility restriction
* use of mobility aids
* insulin therapy
* HbA1c \>12%
* TSH \>10 mU/L
* heart failure (NYHA III, NYHA IV)
* use of obesity pharmacotherapy (orlistat, GLP-1 receptor agonists, GLP-1/GIP dual agonists) for less than 6 months
* weight loss greater than 5 kg in the last 6 months
* chronic kidney disease and estimated glomerular filtration rate \<30 ml/min/1.73 m2
* active treatment of proliferative diabetic retinopathy with anti-VEGF
* heart attack or stroke in the past 1 year
* active malignant disease diagnosed in the past 1 year
* eating disorders
* pregnancy or pregnancy planning
* substance abuse
* learning disabilities
* acute episode of severe depression
* current use of antipsychotics
* food allergy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
69 Years
Study:
NCT07017127
Study Brief:
Protocol Section:
NCT07017127