Dietary Approaches to Stop Hypertension for Diabetes (DASH4D)

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diet, DASH, sodium Read More

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 either the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation or the simplified Modification of Diet in Renal Disease Study (MDRD) equation
  • 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 supplement, except if part of a multivitamin
     • 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
  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 (non-melanoma skin cancer or localized breast or prostate cancer not requiring systemic therapy is acceptable)
  • Active inflammatory bowel disease, bowel resection, malabsorptive syndrome, pancreatitis (episode within past year), or history of bariatric surgery
  • 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 prior 2 months

• 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
  • Planning to leave area prior to end of study
  • Investigator discretion