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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT04416204
Eligibility Criteria:
Inclusion Criteria:
* Age 30-75
* BMI 20-35kg/m\^2
* Participants with type 2 diabetes:
* HbA1c less than or equal to 8.5% on lifestyle therapy or monotherapy with metformin or sulphonylureas (SU); or less than or equal to 7.5% on two oral hypoglycemic agents (Metformin and SU)
Exclusion Criteria:
* Pregnancy or breast feeding
* Morbidities precluding participation
* Participants with type 2 diabetes:
* Therapy with insulin
* SGLT2 inhibitors
* GLP-1 based approaches
* TZDs
* Unstable diabetic retinopathy
* Microalbuminuria
* Macrovascular disease
* Medications affecting GI motility (eg., erythromycin, pramlintide)
* Upper GI disorder/surgery
* Participants without diabetes:
* Medications (except stable thyroid hormone or hormone replacement therapy) that could influence glucose tolerance
* History of diabetes mellitus in first degree family members or prior history of diabetes mellitus or gestational diabetes, or pre-diabetes
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT04416204
Study Brief:
Protocol Section:
NCT04416204