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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT04550468
Eligibility Criteria:
Inclusion Criteria:
* physician-diagnosed T2D of ≥1 year;
* current HbA1c of \< 8.5%;
* BMI: \>25 kg/m2; (as of July 5, 2021, BMI cut off was expanded from 25-40 kg/m2 to higher than 25kg/m2 to facilitate recruitment)
* blood pressure of \<160/99 mm Hg assessed according to guidelines;
* non-smoking;
* not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications;
* 20-79 years old.
Exclusion Criteria:
* Use of exogenous insulin;
* taking more than 2 glucose lowering medications;
* ongoing medical treatment for diseases such as cancer, auto-immune or inflammatory disease, liver or kidney disorders;
* allergy, intolerance or aversion to eggs or any other dietary restrictions (e.g., vegan, breakfast skipping) that will prevent them from following the standardized study diets;
* being unable to follow remote guidance by internet or smartphone
* being unable to follow the controlled diet instructions;.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
79 Years
Study:
NCT04550468
Study Brief:
Protocol Section:
NCT04550468