What is the mechanism of action of this treatment?

Common treatments for high blood pressure include dietary modifications such as the DASH diet, which emphasizes increased intake of fruits, vegetables, and low-fat dairy products while reducing sodium intake. The mechanism of action involves improving nutrient intake, which helps to balance electrolytes and reduce blood volume, thereby lowering blood pressure. Reducing sodium intake specifically decreases fluid retention and vascular resistance, which are key contributors to high blood pressure. These dietary changes are crucial for hypertension patients as they can significantly lower blood pressure, reduce the risk of cardiovascular events, and improve overall heart health.

What side effects are associated with this type of intervention?

Common treatments for high blood pressure include dietary modifications like the DASH diet, which focuses on increasing nutrient intake and reducing sodium. Side effects of such dietary changes are generally minimal but may include gastrointestinal discomfort as the body adjusts to increased fiber intake. For pharmacological treatments, common side effects vary by medication class: diuretics can cause electrolyte imbalances and dehydration; ACE inhibitors may lead to a persistent cough and elevated blood potassium levels; calcium channel blockers can cause swelling in the lower extremities and constipation; and beta-blockers may result in fatigue and cold extremities. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The DASH diet, which emphasizes fruits, vegetables, and low-fat dairy while reducing sodium intake, has been shown to effectively lower blood pressure and is similar to the DASH4D diet being studied. Additionally, FDA-approved antihypertensive medications such as ACE inhibitors (e.g., enalapril, lisinopril) and ARBs (e.g., losartan, valsartan) are commonly used to manage high blood pressure. These drugs work by inhibiting the production or action of angiotensin II, a hormone that causes blood vessels to narrow. Combining dietary modifications like the DASH diet with these medications can provide a comprehensive approach to managing high blood pressure.

What other types of research exist?

Promising alternatives to the DASH4D diet with lower sodium for high blood pressure patients include: 1) Plant-based diets, which have been associated with lower blood pressure and improved cardiovascular health. 2) Low-sodium Mediterranean diet, which combines the benefits of low sodium intake with the heart-healthy components of the Mediterranean diet. 3) Low-sodium vegetarian or vegan diets, which have shown potential in managing blood pressure and improving overall health outcomes. These alternatives should be discussed with a healthcare provider to tailor the best approach for individual needs.

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DASH Diet for High Blood Pressure (DASH4D Trial)

N/A

Waitlist Available

Led By Elizabeth Selvin, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Diabetes Mellitus Type 2 defined by HbA1c ≥6.5% or treatment of diabetes with diabetes medication(s)

Must not have

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

Weight loss or gain of >5.0% of body weight during prior 2 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of 5-week feeding period

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special diet for people with diabetes and different salt levels to see how they affect blood pressure. It focuses on adults with Type 2 diabetes who have moderately high blood pressure. The goal is to find out if healthier food choices and less salt can help lower their blood pressure.

Who is the study for?

Adults with Type 2 Diabetes and blood pressure between 120-159/under 100 mmHg, who can eat on-site meals regularly, have stable weight, no other clinical trials or severe illnesses. Must not be pregnant or planning pregnancy, without significant dietary restrictions that affect adherence.

What is being tested?

The DASH4D trial is testing the effects of a diabetes-modified DASH diet versus a typical American diet and the impact of low versus high sodium intake on blood pressure in people with Type 2 Diabetes through a controlled feeding study.

What are the potential side effects?

There may not be direct side effects from participating as this trial involves dietary changes rather than medication. However, changes in diet can sometimes cause digestive discomfort or alterations in energy levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have Type 2 diabetes with an HbA1c of 6.5% or higher, or I am on diabetes medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is severely reduced.

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I have lost or gained more than 5% of my weight in the last 2 months.

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My arm's circumference is at least 50cm.

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I have Type 1 diabetes.

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I have not had any major heart issues or strokes in the last 6 months.

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I visited the ER for asthma or COPD in the past 6 months.

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I have had recent issues with my digestive system, including surgery or inflammation.

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I needed help or was hospitalized for low blood sugar in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of 5-week feeding period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of 5-week feeding period

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of 5-week feeding period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Systolic blood pressure (SBP)

Secondary study objectives

Diastolic blood pressure (DBP)

Other study objectives

Cardiovascular disease (CVD) risk percentage

Fasting glucose level

Fructosamine level

+26 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Comparison diet with higher sodiumExperimental Treatment2 Interventions

Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day

Group II: DASH4D diet with lower sodiumActive Control2 Interventions

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

Group III: DASH4D diet with higher sodiumActive Control2 Interventions

DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day

Group IV: Comparison diet with lower sodiumActive Control2 Interventions

Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include dietary modifications such as the DASH diet, which emphasizes increased intake of fruits, vegetables, and low-fat dairy products while reducing sodium intake. The mechanism of action involves improving nutrient intake, which helps to balance electrolytes and reduce blood volume, thereby lowering blood pressure. Reducing sodium intake specifically decreases fluid retention and vascular resistance, which are key contributors to high blood pressure. These dietary changes are crucial for hypertension patients as they can significantly lower blood pressure, reduce the risk of cardiovascular events, and improve overall heart health.