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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT06921356
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* Diabetes Mellitus Type 2 defined by: self-reported type 2 diabetes diagnosis, or HbA1c\>=6.5%, or treatment of diabetes with diabetes medications(s)
* Baseline systolic BP 120-159 mmHg (with or without medications.)
* Serum potassium level \>3.0 and \<5 mmol/L,
* Estimated glomerular filtration rate (eGFR) \>=45 mL/min/1.73m2.
* Willing and able to complete required procedures in English.
* Living in Healthy Food Priority Area in Baltimore; the US Department of Agriculture (USDA) defined low income, low access areas, or census blocks with area deprivation index (ADI) 60 and above (State Decile\>=6.)
Exclusion Criteria:
* Hypoglycemia requiring hospitalization or the assistance of another person in the last 6 months
* Cardiovascular event within 6 months
* On diabetes or weight loss medications such as glucagon-like peptide 1 (GLP-1), GLP-1/glucose-dependent insulin-releasing peptide (GIP), insulin, or any combination of these medications
* HbA1c ≥ 10%
* Type 1 diabetes
* Baseline systolic BP \< 100 mmHg
* Weight \>400 lbs due to the maximum weight on study scale
* Chronic disease that might interfere with trial participation
* Current participation in another clinical trial that might affect blood pressure, weight loss, diabetes, or ability to adhere to study procedures
* Current participation in program with conflicting dietary guidance (i.e., meal replacement or keto diets)
* Unwillingness or inability to adopt a DASH-like diet
* Planning to leave area in the next 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06921356
Study Brief:
Protocol Section:
NCT06921356