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New treatment option for Hypertension
Official title Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes
ClinicalTrials.gov ID: NCT06921356
What this study is testing
- What it's testing
- People with high blood pressure and diabetes often have low levels of key nutrients as a result of not eating enough fresh fruits and vegetables. Research studies suggest that these nutrients can lower blood pressure and blood sugar.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- HbA1c ≥ 10%
- Type 1 diabetes
- Baseline systolic BP \< 100 mmHg
See the full eligibility 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.)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.