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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT03444558
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged \>18 years with the metabolic syndrome (as defined by the international criteria: Alberti KG, et al. Circulation. 2009; 120: 1640-5);
* BMI\> 25 kg/m\^2;
* Subjects able to swallow whole tablets;
* Informed consent obtained prior to any study-related activities.
Exclusion Criteria:
* Pregnancy or willingness to become pregnant;
* Severe liver dysfunction (ALT \>2.5 times upper limit of normal);
* Severe renal failure (eGFR\<60 mL/min/1.73 m2 using the MDRD formula);
* Severe infections at the discretion of the investigator (such as HIV, HBV and HCV);
* History or presence of malignant neoplasms within the last 5 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03444558
Study Brief:
Protocol Section:
NCT03444558