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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT04621032
Eligibility Criteria:
Inclusion Criteria:
* gender: female or male,
* age 35-65 years old,
* visceral obesity,
* lack of acute or chronic diseases that may have an influence on rhythm or conduction disorders,
* not undergoing Continuous Positive Airway Pressure therapy (CPAP) or taking drugs that have or may have an influence on QT interval duration \[according to Credible Meds list (Woosley et al, 2019)\],
* not consuming grapefruits or grapefruit juice for at least 2 weeks before Holter-ECG examination.
Exclusion Criteria:
* revealing that information about patient's chronic illness or drugs therapy was obfuscated, revealing increased fasting serum glucose concentration or ionic disturbances. It was strongly recommended to every patient to visit their GP for further diagnostics,
* revealing any important deviation in physical examination i.a. blood pressure taken twice at the visit ≥140/ ≥90 mmHg,
* revealing, upon Holter ECG examination, tachycardia or too numerous artifacts making QT interval assessment incredible,
* too short total sleep time (\< 6 hours) registered on polygraphy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT04621032
Study Brief:
Protocol Section:
NCT04621032