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 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT03534661
Eligibility Criteria:
Inclusion Criteria:
* Men and women, aged 18 to 60 years
* Body mass index 20 kg/m2 to 30 kg/m2
* Hemoglobin above 130g/L.
* Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test
Exclusion Criteria:
* Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
* Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (creatinine \> 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic blood pressure \> 100 or systolic \> 180) or proliferative retinopathy
* History of diabetes or oral glucose tolerance indicative of diabetes or impaired glucose tolerance.
* Any history of a myocardial infarction or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on electrocardiogram, unstable angina, or decompensated heart failure.
* Any laboratory values: aspartate transaminase \> 2x upper limit of normal; alanine aminotransferase \> 2x upper limit of normal; thyroid-stimulating hormone \> 6 miliunit/l
* Current addiction to alcohol or substances of abuse as determined by the investigator.
* Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
* Taking any prescription or non-prescription medications at the time of the study
* Having donated blood three months prior to and three months post study procedures
* A pregnancy test will be performed 1 to 3 days prior to each study in all female research participants. Those who test positive for pregnancy will be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03534661
Study Brief:
Protocol Section:
NCT03534661