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 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT04734132
Eligibility Criteria:
Inclusion Criteria:
* Prediabetes: HbA1c between 5.7-6.4 % or fasting blood glucose between 100 - 125 mg/dl or impaired glucose tolerance (\> 140 mg/dl and \< 200 mg/dl two hours post oral challenge).
* No pharmacological treatment prescribed for glycemia control.
Exclusion Criteria:
* Diabetes Mellitus
* Impaired renal function: \< 60% Glomerular filtration
* Uncontrolled high blood pressure
* Previous cardiovascular events or coronary disease
* Autoimmune disease
* HIV
* Severe gastrointestinal disease
* Cancer
* Psychiatric illness
* Elevated liver enzymes (x2 normal range)
* Alcohol abuse (higher than 14 and 21 doses/week for women and men, respectively)
* Morbid obesity (BMI\>35kg/m2)
* Pregnancy
* Pharmacological treatments that interfere with glucose control.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT04734132
Study Brief:
Protocol Section:
NCT04734132