Diabetes Mellitus, Type 2DASH4DNCT04286555
Dietary Approaches to Stop Hypertension for Diabetes
A study testing DASH4D diet, comparison diet and higher sodium in people with Diabetes Mellitus, Type 2 and Diabetes, run by Johns Hopkins University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes, Diabetes type2
- What is being tested?
- DASH4D diet, comparison diet and higher sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2021to 17 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 48Show fewer
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Approaches to Stop Hypertension for Diabetes Trial
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.
Read the detailed description
DASH4D Main Trial:
In persons with and without diabetes, elevated blood pressure (BP) is the leading cause of stroke and a major risk factor for other cardiovascular diseases, including coronary heart disease and heart failure. Strategies that effectively lower BP include drug therapy and lifestyle modification. Lifestyle modifications, particularly dietary approaches, have been shown to lower BP in persons without diabetes. However, there is a striking dearth of evidence on BP-lowering, lifestyle modifications, other than weight loss, in persons with diabetes. The DASH4D trial is designed to provide this evidence.
The DASH4D trial builds upon the investigators' experience in four NIH-sponsored feeding studies (DASH, DASH-Sodium, OmniHeart, and OmniCarb). The trial will enroll approximately 100 adults with Type 2 diabetes, systolic BP 120-159 mmHg, and diastolic BP <100 mmHg, to determine the effects, alone and combined, of (a) the DASH4D diet (a DASH-style diet modified for people with diabetes) vs. comparison diet (typical of what many Americans with diabetes eat) and (b) lower sodium intake vs. higher sodium intake on BP.
The core design is a four-period, single-site, crossover feeding study with 5-week periods. Participants are fed each of four diets, presented in random order:
- DASH4D diet with lower sodium
- DASH4D diet with higher sodium
- comparison diet with lower sodium
- comparison diet with higher sodium.
The primary contrast of interest is the DASH4D diet with lower sodium vs. the comparison diet with higher sodium.
The DASH4D diet is similar to the original DASH diet, but is lower in carbohydrates and higher in unsaturated fat than the original DASH diet, and therefore, is more consistent with dietary recommendations for persons with diabetes than the original DASH diet. The comparison diet reflects what many persons with diabetes currently consume. The lower sodium intake of approximately 1500 mg/day (at 2000 kcal) has been shown to lower BP in persons without diabetes, and has been recommended in some dietary guidelines. The higher sodium intake of approximately 3700 mg/day (at 2000 kcal) is based on estimated average intake in the US.
Outcomes are measured at the end of each feeding period. The primary outcome is end-of-period, office-based systolic BP. Other outcomes are diastolic BP, measures of glycemia, plasma lipid risk factors, patient symptoms, and estimated cardiovascular disease risk.
Similar to the investigators' prior feeding studies, the investigators expect that the results of the DASH4D trial will be immediately applicable to public health and clinical guidelines and will influence nutrition policy. Furthermore, the trial will provide a rigorous platform to assess the impact of diet and sodium intake on a diverse array of other outcomes in persons with Type 2 diabetes.
DASH4D CONTINUOUS GLUCOSE MONITORING (CGM) ANCILLARY STUDY:
Continuous glucose monitoring (CGM) systems are novel technologies recommended for assessing real-time glucose patterns, biochemical hypoglycemia, and glycemic variability. The DASH4D-CGM ancillary study will offer CGM to all participants in the DASH4D trial during a screening visit and during the two weeks at the end of each of four feeding periods.
CGM outcomes will be based on CGM data captured from week 3 to week 5 (up to 14 days) of each 5-week feeding period. Per current analytic recommendations, CGM outcomes will be generated using all available CGM data for each feeding period. The primary CGM outcomes are mean glucose, time-in-range (percentage of time glucose is between 70 and 180 mg/dL), and coefficient of variation. These outcomes were selected based on clinical guidelines and recommendations from a consensus statement on CGM endpoints for clinical trials.
We hypothesized that salt would have no effect on glucose. Therefore, we plan to combine data from the lower and higher sodium feeding periods for each diet to increase statistical power. Our primary aim is to examine the average difference in mean glucose, time-in-range, and coefficient of variation between the DASH4D and comparison diets.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes, Diabetes type2, Type2 Diabetes, Type 2 Diabetes, Type II Diabetes
- Being tested
- DASH4D diet, comparison diet, higher sodium, lower sodium
- Keywords
- diet, DASH, sodium
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH4D dietOther
DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate.
comparison dietOther
The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
higher sodiumOther
3700 mg/day sodium (at the 2000 kilocalorie level)
lower sodiumOther
1500 mg/day sodium (at the 2000 kilocalorie level)
| Study group | Role | What they receive |
|---|---|---|
| DASH4D diet with lower sodium | Active comparator | DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day Receives: Other: DASH4D diet; Other: lower sodium |
| DASH4D diet with higher sodium | Active comparator | DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day Receives: Other: DASH4D diet; Other: higher sodium |
| Comparison diet with lower sodium | Active comparator | Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day Receives: Other: comparison diet; Other: lower sodium |
| Comparison diet with higher sodium | Other | Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day Receives: Other: comparison diet; Other: higher sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure (SBP)
After the participant has rested quietly in the seated position for at least 5 minutes, blood pressure will be measured in triplicate, using an Omron device, with each reading separated by 30 seconds, and the average of the three readings (in mmHg) will also be recorded. Blood pressure will be measured on five separate occasions during the last 2 weeks of the feeding period, and the mean systolic blood pressure from these five blood pressures (15 total readings) will be used as the primary outcome.
Measured: At the end of 5-week feeding period
Secondary outcomes (1)
Diastolic Blood Pressure (DBP)
After the participant has rested quietly in the seated position for at least 5 minutes, blood pressure will be measured in triplicate, using an Omron device, with each reading separated by 30 seconds, and the average of the three readings (in mmHg) will also be recorded. Blood pressure will be measured on five separate occasions during the last 2 weeks of the feeding period, and the mean diastolic blood pressure from these five blood pressures (15 total readings) will be used as a secondary outcome.
Measured: At the end of 5-week feeding period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start2 Jun 2021
- Primary completion13 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study design is a four-period crossover feeding study, in which participants will be randomly assigned to an order of four isocaloric diets for a 5-week period each.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sheikh Khalifa Stroke Institute at Johns Hopkins, University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Lawrence Appel, MD, MPH, Principal investigator, Johns Hopkins UniversityHsin Chieh Yeh, PhD, Principal investigator, Johns Hopkins UniversityScott Pilla, MD, MHS, Principal investigator, Johns Hopkins UniversityElizabeth Selvin, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286555
- Sponsor's protocol ID
- IRB00232059
- Other IDs
- R01DK128900
- Acronym
- DASH4D
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2020
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fang M, Wang D, Rebholz CM, Echouffo-Tcheugui JB, Tang O, Wang NY, Mitchell CM, Pilla SJ, Appel LJ, Selvin E. DASH4D diet for glycemic control and glucose variability in type 2 diabetes: a randomized crossover trial. Nat Med. 2025 Oct;31(10):3309-3316. doi: 10.1038/s41591-025-03823-3. Epub 2025 Aug 5.
PubMed 40764427Pilla SJ, Yeh HC, Mitchell CM, Miller ER 3rd, Oh S, White K, Durkin N, Stein AA, Charleston JB, Lu M, Hu X, Wu B, Selvin E, Fang M, Maruthur NM, Juraschek SP, Mueller NT, Wang NY, Appel LJ; DASH4D Collaborative Research Group. Dietary Patterns, Sodium Reduction, and Blood Pressure in Type 2 Diabetes: The DASH4D Randomized Clinical Trial. JAMA Intern Med. 2025 Aug 1;185(8):937-946. doi: 10.1001/jamainternmed.2025.1580.
PubMed 40489102
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Approaches to Stop Hypertension for Diabetes Trial
- ClinicalTrials.gov ID
- NCT04286555
- Acronym / sponsor ID
- DASH4D / IRB00232059
- Conditions
- Diabetes Mellitus, Type 2, Diabetes, Diabetes type2, Type2 Diabetes, Type 2 Diabetes, Type II Diabetes
- Keywords
- diet, DASH, sodium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sheikh Khalifa Stroke Institute at Johns Hopkins, University of Colorado, Denver
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Posted 13 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
DASH4D Main Trial:
In persons with and without diabetes, elevated blood pressure (BP) is the leading cause of stroke and a major risk factor for other cardiovascular diseases, including coronary heart disease and heart failure. Strategies that effectively lower BP include drug therapy and lifestyle modification. Lifestyle modifications, particularly dietary approaches, have been shown to lower BP in persons without diabetes. However, there is a striking dearth of evidence on BP-lowering, lifestyle modifications, other than weight loss, in persons with diabetes. The DASH4D trial is designed to provide this evidence.
The DASH4D trial builds upon the investigators' experience in four NIH-sponsored feeding studies (DASH, DASH-Sodium, OmniHeart, and OmniCarb). The trial will enroll approximately 100 adults with Type 2 diabetes, systolic BP 120-159 mmHg, and diastolic BP <100 mmHg, to determine the effects, alone and combined, of (a) the DASH4D diet (a DASH-style diet modified for people with diabetes) vs. comparison diet (typical of what many Americans with diabetes eat) and (b) lower sodium intake vs. higher sodium intake on BP.
The core design is a four-period, single-site, crossover feeding study with 5-week periods. Participants are fed each of four diets, presented in random order:
- DASH4D diet with lower sodium
- DASH4D diet with higher sodium
- comparison diet with lower sodium
- comparison diet with higher sodium.
The primary contrast of interest is the DASH4D diet with lower sodium vs. the comparison diet with higher sodium.
The DASH4D diet is similar to the original DASH diet, but is lower in carbohydrates and higher in unsaturated fat than the original DASH diet, and therefore, is more consistent with dietary recommendations for persons with diabetes than the original DASH diet. The comparison diet reflects what many persons with diabetes currently consume. The lower sodium intake of approximately 1500 mg/day (at 2000 kcal) has been shown to lower BP in persons without diabetes, and has been recommended in some dietary guidelines. The higher sodium intake of approximately 3700 mg/day (at 2000 kcal) is based on estimated average intake in the US.
Outcomes are measured at the end of each feeding period. The primary outcome is end-of-period, office-based systolic BP. Other outcomes are diastolic BP, measures of glycemia, plasma lipid risk factors, patient symptoms, and estimated cardiovascular disease risk.
Similar to the investigators' prior feeding studies, the investigators expect that the results of the DASH4D trial will be immediately applicable to public health and clinical guidelines and will influence nutrition policy. Furthermore, the trial will provide a rigorous platform to assess the impact of diet and sodium intake on a diverse array of other outcomes in persons with Type 2 diabetes.
DASH4D CONTINUOUS GLUCOSE MONITORING (CGM) ANCILLARY STUDY:
Continuous glucose monitoring (CGM) systems are novel technologies recommended for assessing real-time glucose patterns, biochemical hypoglycemia, and glycemic variability. The DASH4D-CGM ancillary study will offer CGM to all participants in the DASH4D trial during a screening visit and during the two weeks at the end of each of four feeding periods.
CGM outcomes will be based on CGM data captured from week 3 to week 5 (up to 14 days) of each 5-week feeding period. Per current analytic recommendations, CGM outcomes will be generated using all available CGM data for each feeding period. The primary CGM outcomes are mean glucose, time-in-range (percentage of time glucose is between 70 and 180 mg/dL), and coefficient of variation. These outcomes were selected based on clinical guidelines and recommendations from a consensus statement on CGM endpoints for clinical trials.
We hypothesized that salt would have no effect on glucose. Therefore, we plan to combine data from the lower and higher sodium feeding periods for each diet to increase statistical power. Our primary aim is to examine the average difference in mean glucose, time-in-range, and coefficient of variation between the DASH4D and comparison diets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study design is a four-period crossover feeding study, in which participants will be randomly assigned to an order of four isocaloric diets for a 5-week period each.
| Arm | Type | Receives |
|---|---|---|
| DASH4D diet with lower sodium | Active comparator | Other: DASH4D diet, Other: lower sodiumDASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day |
| DASH4D diet with higher sodium | Active comparator | Other: DASH4D diet, Other: higher sodiumDASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day |
| Comparison diet with lower sodium | Active comparator | Other: comparison diet, Other: lower sodiumDietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day |
| Comparison diet with higher sodium | Other | Other: comparison diet, Other: higher sodiumDietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (48 listed)
- Laboratory Exclusions
- Medication Exclusions
- Medical History Exclusions
- Physical Exclusions
- Lifestyle and Other Exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH4D dietDASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate. | Other | DASH4D diet with higher sodium, DASH4D diet with lower sodium |
| comparison dietThe comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium). | Other | Comparison diet with higher sodium, Comparison diet with lower sodium |
| higher sodium3700 mg/day sodium (at the 2000 kilocalorie level) | Other | Comparison diet with higher sodium, DASH4D diet with higher sodium |
| lower sodium1500 mg/day sodium (at the 2000 kilocalorie level) | Other | Comparison diet with lower sodium, DASH4D diet with lower sodium |
Primary outcome
Systolic Blood Pressure (SBP)
Time frame: At the end of 5-week feeding period
After the participant has rested quietly in the seated position for at least 5 minutes, blood pressure will be measured in triplicate, using an Omron device, with each reading separated by 30 seconds, and the average of the three readings (in mmHg) will also be recorded. Blood pressure will be measured on five separate occasions during the last 2 weeks of the feeding period, and the mean systolic blood pressure from these five blood pressures (15 total readings) will be used as the primary outcome.
1 secondary outcome
Diastolic Blood Pressure (DBP)
Time frame: At the end of 5-week feeding period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40764427Fang M, Wang D, Rebholz CM, Echouffo-Tcheugui JB, Tang O, Wang NY, Mitchell CM, Pilla SJ, Appel LJ, Selvin E. DASH4D diet for glycemic control and glucose variability in type 2 diabetes: a randomized crossover trial. Nat Med. 2025 Oct;31(10):3309-3316. doi: 10.1038/s41591-025-03823-3. Epub 2025 Aug 5.
- Derived from this study: PubMed 40489102Pilla SJ, Yeh HC, Mitchell CM, Miller ER 3rd, Oh S, White K, Durkin N, Stein AA, Charleston JB, Lu M, Hu X, Wu B, Selvin E, Fang M, Maruthur NM, Juraschek SP, Mueller NT, Wang NY, Appel LJ; DASH4D Collaborative Research Group. Dietary Patterns, Sodium Reduction, and Blood Pressure in Type 2 Diabetes: The DASH4D Randomized Clinical Trial. JAMA Intern Med. 2025 Aug 1;185(8):937-946. doi: 10.1001/jamainternmed.2025.1580.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Appel, MD, MPH principal investigator
Johns Hopkins University
Hsin Chieh Yeh, PhD principal investigator
Johns Hopkins University
Scott Pilla, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH4D diet, comparison diet and higher sodium in people with Diabetes Mellitus, Type 2 and Diabetes, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (SBP) (time frame: At the end of 5-week feeding period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04286555, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.