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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT06092060
Eligibility Criteria:
Inclusion Criteria:
* women 25-45 years old, menstruating, BMI 25-32.9 kg / m2, insulin resistance based on the HOMA-IR index (cut-off point 2.5
Exclusion Criteria:
* type 1 and 2 diabetes,
* poorly controlled arterial hypertension (mean SBP values\> 140mmHg and / or mean DBP values\> 90mmHg) within the last month and / or the need to modify pharmacological treatment,
* 2nd degree obesity, BMI\> 35 kg / m2,
* lipid disorders requiring pharmacological treatment in the last 3 months before the start of observation or during observation,
* positive history of ischemic heart disease, carotid and / or lower limb atherosclerosis,
* features of heart failure on physical examination and / or additional examinations (chest X-ray, echocardiography),
* clinically significant arrhythmias or conduction disturbances,
* chronic kidney disease with creatinine clearance \<60mL / min / 1.73m2,
* clinically significant impairment of liver function (transaminase values 3 times the normal range),
* acute or chronic, clinically evident inflammatory process (diseases of connective tissue and joints, inflammatory processes of the respiratory tract, inflammatory processes of the genitourinary system, inflammation of the head and neck),
* acute infection in the last month,
* Cancer,
* alcohol abuse, drug addiction,
* taking medications that may interfere with test results,
* Taking antibiotics, steroids, antifungal and antiparasitic agents 4 weeks before the examination (not applicable to topical antifungal agents).
* taking pre - and / or probiotics in the last 12 weeks before the test
* travel to tropical countries in the last 4 weeks prior to the survey
* other conditions that may pose any risk to the patient during the follow-up.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
45 Years
Study:
NCT06092060
Study Brief:
Protocol Section:
NCT06092060