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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT01087632
Eligibility Criteria:
Inclusion Criteria:
Male and Female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference \> 102 cm (M) or \>88 cm(F), and two or more of these criteria:
* fasting blood glucose \>100 mg;
* systolic blood pressure \>135 or diastolic blood pressure \>85 mmHg or patients in treatment with antihypertensive drugs;
* triglyceridemia \>150 mg/dl;
* HDL cholesterolemia \< 40 mg/dl(M), \< 50 mg/dl(F).
Exclusion Criteria:
* pregnancy
* diabetes mellitus in pharmacologic treatment;
* hepatic failure;
* creatininemia \>2 mg/dl;
* triglyceridemia \> 500 mg/dl;
* heart failure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01087632
Study Brief:
Protocol Section:
NCT01087632