Dietary Approaches to Stop Hypertension for Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT04286555
• Date of registration: 25/02/2020
• Prospective Registration: Yes
• Primary sponsor: Johns Hopkins University
• Public title: Dietary Approaches to Stop Hypertension for Diabetes DASH4D
• Scientific title: Dietary Approaches to Stop Hypertension for Diabetes Trial
• Date of first enrolment: June 2, 2021
• Target sample size: 105
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04286555
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Hsin Chieh Yeh, PhD
• Affiliation: Johns Hopkins University

• Name: Lawrence Appel, MD, MPH
• Affiliation: Johns Hopkins University

• Name: Scott Pilla, MD, MHS
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

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 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

High Blood Pressure

Hypertension

Type2 Diabetes

Type 2 Diabetes

Diabetes Mellitus, Type 2

Type II Diabetes

Diabetes type2

Diabetes

Intervention(s)

Other: DASH4D diet

Other: lower sodium

Other: comparison diet

Other: higher sodium

Primary Outcome(s)

Systolic blood pressure (SBP) [Time Frame: At the end of 5-week feeding period]

Secondary Outcome(s)

Fructosamine level [Time Frame: At the end of 5-week feeding period]

Total cholesterol level [Time Frame: At the end of 5-week feeding period]

Fasting glucose level [Time Frame: At the end of 5-week feeding period]

Postural change in systolic blood pressure [Time Frame: At the end of 5-week feeding period]

Symptoms experienced by participants as assessed by a questionnaire [Time Frame: At the end of 5-week feeding period]

Low-density lipoprotein (LDL) cholesterol level [Time Frame: At the end of 5-week feeding period]

Cardiovascular disease (CVD) risk percentage [Time Frame: At the end of 5-week feeding period]

Diastolic blood pressure (DBP) [Time Frame: At the end of 5-week feeding period]

Postural change in diastolic blood pressure [Time Frame: At the end of 5-week feeding period]

Triglyceride level [Time Frame: At the end of 5-week feeding period]

Hemoglobin A1c (HbA1c) level [Time Frame: At the end of 5-week feeding period]

Glycated albumin level [Time Frame: At the end of 5-week feeding period]

High-density lipoprotein (HDL) cholesterol level [Time Frame: At the end of 5-week feeding period]

Presence of orthostatic hypotension [Time Frame: At the end of 5-week feeding period]

Secondary ID(s)

IRB00232059

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Beth Israel Deaconess Medical Center