Dietary Approaches to Stop Hypertension for Diabetes

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 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
• 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.