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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT04003194
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of T2DM by a physician;
* currently attempting control of T2DM by diet or metformin;
* fasting glucose ≥ 90 mg/dL (confirmed by fasting blood draw or potential participant provided lab analysis conducted within last 30 days) and/or hemoglobin A1C ≥ 6.5% (confirmed by blood draw or potential participant provided lab analysis conducted within last 30 days);
* body mass index (BMI) of 22-40 kg/m2;
* no unresolved health conditions and no diagnosis of gastrointestinal disease;
* limited history of legume intake;
* willingness to follow study protocol, scheduling, and ability to come to the testing location;
* no recent weight gain or loss (\>10% over 6 months);
* no use of medications and/or dietary supplements other than metformin that affected glucose;
* women could not be pregnant or breastfeeding;
* habitual alcohol consumption had to be less than 2 drinks per day (specifically ≤ 720 ml of beer, 240 ml of wine, or 90 ml of hard liquor).
Exclusion Criteria:
* Non compliance with above inclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT04003194
Study Brief:
Protocol Section:
NCT04003194