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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT02150356
Eligibility Criteria:
Inclusion Criteria:
* Overweight/obese subjects of both gender
* Age range between 20 and 70 years
* High cardiovascular and metabolic risk profile will be enrolled in the study
* Waist circumference \> 102 cm for men, and \> 88 cm for women
* At least one of the characteristics of the metabolic syndrome according to the NCEP/ATP III criteria:
* Fasting triglycerides ≥150 mg/dl
* High-density lipoprotein cholesterol \<40 mg/dl (men)/\<50 mg/dl (women)
* Blood pressure ≥ 130/85 mmHg
* Fasting glucose ≥100 mg/dl
Exclusion Criteria:
* Age \<20 and \>70 years
* Fasting triglycerides ≥400 mg/dl
* Fasting cholesterol \>270 mg/dl
* Cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study; established diabetes mellitus or any chronic disease
* Renal and liver failure (creatinine \>1.7 mg/dl and ALT/AST \>2 times than normal values, respectively)
* Anaemia (Hb \<12 g /dl)
* Any chronic disease
* People treated with antihypertensive drugs will have to keep the type and dosage of medication unchanged during the whole study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02150356
Study Brief:
Protocol Section:
NCT02150356