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 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT04456192
Eligibility Criteria:
Inclusion Criteria:
Initial inclusion criteria for both study groups were as follows: age: 30 to 65 years and stable body weight in the month prior to the trial (permissible deviation ± 1 kg).
For Women with Obesity Group: BMI ≥ 30 kg/m2; waist circumference \> 80 cm. For Normal-weight Womeng Group: BMI ≤ 24.9 and ≥ 18.5 kg/m2
Exclusion Criteria for both study groups were as follows:
* secondary form of obesity and/or secondary form of hypertension;
* diabetes mellitus;
* history of coronary artery disease;
* stroke;
* congestive heart failure;
* clinically significant arrhythmias or conduction disorders;
* malignancy;
* poorly controlled hypertension (SBP \> 140 mmHg and/or DBP \> 90 mmHg), and/or modifications to antihypertensive treatment;
* lipid disorders requiring the implementation of drug treatment;
* clinically significant abnormalities in liver, kidney or thyroid gland function;
* clinically significant acute or chronic inflammatory process within the respiratory, digestive or genitourinary tracts, or the oral cavity, pharynx or paranasal sinuses; or, presence of connective tissue disease or arthritis;
* history of infection within the month prior to the study;
* nicotine, alcohol or drug abuse;
* and / or any other condition which, according to the researchers, would cause that participation would be detrimental to the participant or would prevent, limit or interfere with the results of the study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT04456192
Study Brief:
Protocol Section:
NCT04456192