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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT05199350
Eligibility Criteria:
Inclusion Criteria:
1. Able to provide informed consent
2. Age between 18 to 85
3. Body Mass Index (BMI) between 25 and 40 kg/m2
4. Individuals with normal glucose levels, pre-diabetes and diabetes Type 2 for at least 1 year (diagnosed by ADA criteria) and up to 20 years
5. Stable dose of meds for 3 months
6. Stable diet and lifestyle for 3 months
7. Medical history without clinically significant abnormalities
Exclusion Criteria:
1. Have a disorder that would impede performing the HRV measurement procedure (i.e., abnormal cardiac rhythm, heart disease, including coronary artery disease, angina, and arrhythmia, cardiac pacemaker, stroke, panic attack, cognitive impairment, renal failure)
2. Chronic disease (e.g. HIV, Cushing syndrome, CKD, acromegaly, active hyperthyroidism etc.)
3. Cancer and anticancer treatment in the last 5 years
4. Pregnancy or lactation
5. Subjects with major physical disability
6. Subjects with previous history of cerebrovascular accident
7. Any disorder, which in the investigator's opinion might jeo
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05199350
Study Brief:
Protocol Section:
NCT05199350