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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT06358859
Eligibility Criteria:
Inclusion Criteria:
* Patient at participating Delta Health Center (DHC) clinics
* BMI: ≥ 25
* Hemoglobin A1C (HbA1c): \>5.7 to 8.5%, inclusive
Exclusion Criteria:
* Type 1 diabetes
* Current use of incretin agonists (e.g., semaglutide, dulaglutide, liraglutide)
* Uncontrolled hypertension:
* Systolic blood pressure \> 160 mmHg
* Diastolic blood pressure \> 100 mmHg
* Severe symptomatic cardiovascular disease
* Recent (6 months) history of:
* Myocardial infarction
* Percutaneous coronary intervention
* Coronary artery bypass graft
* Cerebrovascular disease
* Participant in diabetes, nutrition, or weight intervention research in the last 12 months
* Another family member or household member is a study participant
* History of bariatric surgery or considering bariatric surgery in the next year or prior bariatric surgery
* Lack of safe, stable residence and ability to store produce
* Lack of telephone
* Pregnancy/breastfeeding or intended pregnancy in the next year
* Drug or alcohol misuse that would impair the ability to complete study activities
* Known psychosis or major psychiatric illness that prevents participation in study activities
* Any other reason that in the investigators' best judgment places the participants at risk or increases likelihood of poor adherence
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06358859
Study Brief:
Protocol Section:
NCT06358859