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Can a Heart-Healthy diet tame blood pressure in diabetes?

NCT ID NCT04286555

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a DASH-style diet (modified for diabetes) combined with lower salt intake can lower blood pressure in adults with type 2 diabetes and high blood pressure. 105 participants ate specially prepared meals for 5-week periods. The goal was to find a practical way to manage both conditions through diet.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

105 people

The number who actually took part.

Started

Jun 2021

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA: * 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 EXCLUSION CRITERIA: * 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 1. 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 2. 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) 3. Unwillingness to keep same dose of vitamin, mineral, and botanical supplements 4. 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 * Cancer diagnosis or treatment in the last 2 years (benign tumors or non-melanoma skin cancer or localized breast or prostate cancer not requiring chemotherapy is acceptable) * Active inflammatory bowel disease, bowel resection, malabsorptive syndrome, pancreatitis (episode within past year), history of Roux-en-Y gastric bypass, or history of other bariatric surgery that limits food intake volume or that requires a specific diet plan * Pregnancy or lactation or planned pregnancy * Any emergency department (ED) visit for asthma or chronic obstructive pulmonary disease (COPD) in the last 6 months * Any other serious illness or condition not compatible with participation as determined by the investigators * Physical Exclusions * Body weight \>420 pounds * Arm circumference ≥50cm * Weight loss or gain of \>5.0% of body weight during 2 months prior to screening, or large weight change during screening prior to randomization * Lifestyle and Other Exclusions * Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence * Not able to self-monitor glucose if needed * Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week * Active substance use disorder that would interfere with participation * Participation in or planning to start weight loss program * Current participation in another clinical trial that might affect blood pressure or ability to comply with study procedures * Planning to leave area prior to end of study * Investigator discretion DASH4D-CGM ANCILLARY STUDY EXCLUSION CRITERIA: All DASH4D main trial participants will be invited to participate in the embedded CGM ancillary study. Participants with the following contraindications to wearing a CGM sensor will be excluded from the ancillary study: * History of allergic skin reaction to adhesive * Implantable pacemaker Note: Participants excluded from, or who do not wish to participate in, the CGM ancillary study are still allowed to participate in the DASH4D main trial if eligible.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Johns Hopkins ProHealth

    Baltimore, Maryland, 21207, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.