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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT06686069
Eligibility Criteria:
Inclusion Criteria:
* consented male and female patients aged 20-70 years with Body Mass Index (BMI) \>25 kg/m2,
* pre-diabetes (fasting glucose 100-125 mg/dL and HbA1c 5.7-6.5%) or metabolic syndrome, defined according to modified NCEP-ATP III criteria (Grundy SM et al., Circulation, 2005) as the presence of three or more of the following clinical features: blood glucose levels \>100 mg/dL, HDL-cholesterol \<40 mg/dL in males and \<50 mg/dL in females, triglycerides levels \>150 mg/dL, waist circumference \>102 cm in males and \>88 cm in females and hypertension, defined as repeated blood pressure measurements \>130/85 mmHg.
Exclusion Criteria:
* moderate to severe renal impairment (calculated creatinine clearance (CrCl) \<60 mL/min according to the Cockcroft-Gault formula);
* hepatic dysfunction (ALT/AST \>3 x upper limit of normal and total bilirubin \>3 mg/dL);
* hypoalbuminemia (serum albumin \<3 g/dL);
* history of any past or current clinically significant cardiovascular diseases;
* monogenic, secondary and pharmacological causes of diabetes and obesity;
* any other clinical condition/disease that the Principal Investigator believes might confound study outcome;
* patients on treatment with insulin or any anti-diabetic drugs or medications known to influence glucose tolerance will also be excluded;
* pregnant or breast-feeding women.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06686069
Study Brief:
Protocol Section:
NCT06686069