Dietary Approaches to Stop Hypertension for Diabetes

NCT04286555 | Completed DMC

• 2 other identifiers: IRB00232059R01DK128900
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Diabetes Mellitus, Type 2; Diabetes; Diabetes type2; Type2 Diabetes; Type 2 Diabetes; Type II Diabetes; Hypertension; High Blood Pressure

Keywords

diet; DASH; sodium

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of 5-week feeding period

Secondary Outcomes (1)

• Diastolic blood pressure (DBP)

  At the end of 5-week feeding period

Other Outcomes (29)

• Glycated albumin level

  At the end of 5-week feeding period

• Fructosamine level

  At the end of 5-week feeding period

• Fasting glucose level

  At the end of 5-week feeding period

Study Arms (4)

DASH4D diet with lower sodium

ACTIVE COMPARATOR

DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day

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

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

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

Other: comparison diet; Other: higher sodium

Interventions

DASH4D diet OTHER

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.

DASH4D diet with higher sodium; DASH4D diet with lower sodium

comparison diet OTHER

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).

Comparison diet with higher sodium; Comparison diet with lower sodium

higher sodium OTHER

3700 mg/day sodium (at the 2000 kilocalorie level)

Comparison diet with higher sodium; DASH4D diet with higher sodium

lower sodium OTHER

1500 mg/day sodium (at the 2000 kilocalorie level)

Comparison diet with lower sodium; DASH4D diet with lower sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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%
• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Beth Israel Deaconess Medical Center: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Sheikh Khalifa Stroke Institute at Johns Hopkins: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

Johns Hopkins ProHealth

Baltimore, Maryland, 21207, United States

Location

Related Publications (2)

• 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.

  PMID: 40764427 DERIVED

• Pilla 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.

  PMID: 40489102 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lawrence Appel, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Hsin Chieh Yeh, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Scott Pilla, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Elizabeth Selvin, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators and the outcomes assessors will not know which order of diets the participant has been assigned. The participant will not be explicitly told which diet he or she is receiving during each period, but by the nature of higher sodium vs. lower sodium or the differences between the DASH4D and comparison diet, the participant would likely be able to guess based on the menus and taste.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: June 2, 2021
• Primary Completion: June 13, 2024
• Study Completion: June 17, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)