Dietary Approaches to Stop Hypertension for Diabetes

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Diabetes, Diabetes type2, Type2 Diabetes, Type 2 Diabetes, Type II Diabetes, Hypertension, High Blood Pressure

In brief

The objective of the DASH4D trial is to determine the effects, alone and combined, of (a) the DASH4D diet (a DASH-style diet modified for people with diabetes) vs. comparison diet that is typical of what many Americans with diabetes eat and (b) lower sodium intake vs. higher sodium intake on blood pressure (BP). The core design is a single-site, 4-period, crossover feeding study with 5-week periods. Participants are fed each of four isocaloric diets, presented in random order. The primary contrast of interest is DASH4D diet with lower sodium vs. comparison diet with higher sodium.

Key facts

Study ID

NCT04286555

Run by

Johns Hopkins University

People needed

105

Starts

2021-06-02

Expected to finish

2024-06-17

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• Diabetes Mellitus Type 2 defined by HbA1c ≥6.5% or treatment of diabetes with diabetes medication(s)
• Baseline systolic BP of 120-159 mmHg (based on average across 3 screening visits)
• Baseline diastolic BP <100 mmHg (based on average across 3 screening visits)
• Willing and able to eat on site for one meal per day, 3 days per week, and eat only and all food provided as part of the study diets during the controlled feeding periods (run-in and four 5-week feeding periods). Note that actual frequency of on-site dining may be fewer than 3 days per week due to COVID-related restrictions, but participants will still need to be on site to pick up food and be weighed 3 days per week, and will still be expected to have meals monitored (in-person or remotely) for one meal per day, 3 days per week.
• Willing and able to complete required measurement procedures
• Have access to a mobile device or computer with video conference capabilities, or be willing to use a device for video conferencing provided by the study

You may not qualify if…

• Laboratory Exclusions
• Serum potassium ≥5.2 mmol/L or <3.5 mmol/L
• Estimated glomerular filtration rate (eGFR) <30 mL/min by commercial lab result (note that prior to 7/12/22, the lab was using the race-based Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation, and on/after 7/12/22, the lab switched to using the CKD-EPI 2021 equation, which does not provide different estimated GFR by race))
• HbA1c>9.0%
• Medication Exclusions
• Unstable dose (i.e., change in the 2 months prior to screening or prior to randomization) of any of the following:
• Anti-hypertensive medications
• Sodium-glucose co-transporter 2 (SGLT2) inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists
• Stimulants, including oral medications for asthma or chronic obstructive pulmonary disease (COPD)
• Hormone replacement therapy or thyroid hormone
• Weight-increasing psychotropic agents, including antipsychotic agents, lithium, and mirtazapine
• Use of any of the following medications:
• Potassium supplementation in any form, including a multivitamin or electrolyte drink mix, with a dose >99 mg/day, which is the allowable amount in over-the-counter products
• Prandial or short-acting insulin
• GLP-1 receptor agonist if on weight loss dose
• Warfarin (Coumadin)
• Chronic oral corticosteroid (intermittent use is okay)
• Weight loss medications
• Tirzepatide (Mounjaro)
• Unwillingness to keep same dose of vitamin, mineral, and botanical supplements
• Any medication not compatible with participation as determined by the investigators
• Medical History Exclusions
• Type 1 diabetes
• Hypoglycemia requiring hospitalization or the assistance of another person in the last 12 months
• Active cardiovascular disease or any event in the prior 6 months, including coronary artery bypass grafting (CABG), percutaneous transluminal coronary angioplasty (PTCA), myocardial infarction (MI), cerebrovascular accident (CVA), or congestive heart failure (CHF) exacerbation requiring hospital admission

Where it is running

• Johns Hopkins ProHealth — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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