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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT04528693
Eligibility Criteria:
Inclusion Criteria:
* women,
* age: 25-45years,
* menstruating,
* BMI 18,5-29,9 kg/m2,
* insulin resistance based on HOMA -IR (cut-off point 2.5),
* not contraindicated to physical activity.
Exclusion Criteria:
* type 1 and 2 diabetes,
* poorly controlled hypertension (mean SBP \>140mmHg and/or mean DBP \>90mmHg) over the last month and/or need to modify the pharmacological treatment,
* obesity: BMI \> 30 kg/m2,
* lipid disorders requiring implementation of pharmacological treatment in the last 3 months before or during observation,
* a positive history of ischemic heart disease, carotid atherosclerosis and / or lower limb atherosclerosis,
* clinically significant arrhythmias or conduction disorders,
* chronickidney disease,
* clinically significant liver dysfunction,
* acute or chronic, clinically manifest inflammatory process,
* an acute infection in the last month,
* cancer,
* taking dietary supplements within a month before inclusion and during observation,
* taking medication that could interfere with the results of the tests,
* other conditions that may pose any risk to the patient during the observation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
45 Years
Study:
NCT04528693
Study Brief:
Protocol Section:
NCT04528693