Highlights
- Sodium reduction, with or without a specialized DASH diet, results in significant blood pressure lowering in adults with type 2 diabetes.
- The majority of the antihypertensive effect was attributable to sodium reduction rather than the DASH diet modification.
- Even in a population on multiple antihypertensive agents, dietary sodium restriction delivered further clinically relevant reductions in both systolic and diastolic blood pressure.
- Adverse effects were infrequent, supporting the safety of dietary sodium reduction in this high-risk group.
Study Background and Disease Burden
Type 2 diabetes mellitus (T2DM) is a leading contributor to global cardiovascular morbidity and mortality, often coexisting with hypertension. Individuals with both conditions face a markedly elevated risk for cardiovascular events, such as myocardial infarction and stroke. While antihypertensive medications are foundational in risk mitigation, many patients remain above target blood pressure thresholds. Dietary modification, particularly sodium intake reduction, is recommended by guidelines, but robust evidence directly supporting these strategies—especially beyond weight loss—remains limited in populations with T2DM.
The Dietary Approaches to Stop Hypertension (DASH) diet has strong evidence for lowering blood pressure in non-diabetic populations, but its effects, especially when tailored for diabetes, have not been systematically evaluated. The DASH4D trial was designed to fill this evidence gap, providing rigorous data on the impact of dietary patterns and sodium reduction in adults with T2DM and hypertension.
Study Design
The DASH4D (Dietary Approaches to Stop Hypertension for Diabetes) trial was a randomized, four-period crossover feeding study conducted at a single community-based center from June 2021 to June 2024. The study enrolled 102 adults with T2DM, a systolic blood pressure (SBP) of 120–159 mm Hg, and a diastolic blood pressure (DBP) below 100 mm Hg. Notably, 66% of participants were on two or more antihypertensive medications at baseline, reflecting a population with substantial residual cardiovascular risk.
Participants received all meals from the study center, eliminating dietary confounders such as non-study food intake. The intervention compared four 5-week diet periods, each separated by a washout:
1. DASH4D diet with lower sodium,
2. DASH4D diet with higher sodium,
3. Comparison (typical US) diet with lower sodium,
4. Comparison diet with higher sodium (reference).
The DASH4D diet was adapted from the original DASH diet to fit the metabolic needs of diabetes: it was lower in carbohydrates, higher in unsaturated fats, and lower in potassium. Body weight was held constant throughout the study to isolate dietary composition effects from those of weight change. The primary endpoint was end-of-period SBP; the secondary endpoint was DBP.
Key Findings
Eighty-five participants (83.3%) completed all four diet periods. Baseline characteristics included a mean age of 66 years, 66% women, and a predominantly Black cohort (87%). Mean baseline blood pressure was 135/75 mm Hg.
The main comparison—DASH4D diet with lower sodium versus comparison diet with higher sodium—revealed:
- SBP reduction of 4.6 mm Hg (95% CI, 7.2–2.0; P<.001)
- DBP reduction of 2.3 mm Hg (95% CI, 3.7–0.9)
Most blood pressure reduction occurred within the first three weeks of each dietary period. Importantly, the magnitude of BP lowering was greater for sodium reduction than for the DASH4D dietary pattern per se. Adverse events were rare and did not differ meaningfully between diet arms, supporting the intervention’s safety.
These findings are clinically significant, given that most participants were already on multiple antihypertensive agents. The incremental SBP reduction of 4–5 mm Hg is likely to translate into meaningful reductions in cardiovascular risk, as established by prior epidemiological and interventional studies.
Expert Commentary
The DASH4D trial addresses a critical gap in the literature by rigorously evaluating diet-based interventions in T2DM patients with hypertension. The crossover design, strict control of dietary intake, and maintenance of stable body weight strengthen the validity of the findings. The study’s emphasis on sodium reduction aligns with 2023 American Diabetes Association and American Heart Association guidelines, which recommend sodium intake below 2,300 mg per day for adults, and even lower for those with hypertension.
However, several considerations remain:
– The highly controlled feeding environment limits direct generalizability to free-living populations, where adherence and access may be more variable.
– The sample was predominantly Black and older adults (mean age 66), populations with high hypertension prevalence but who may differ in dietary responses from other groups.
– The trial was not powered to assess hard clinical endpoints (e.g., cardiovascular events), and follow-up was limited to short-term blood pressure effects.
Nevertheless, the robust blood pressure reduction observed—even with concurrent antihypertensive pharmacotherapy—underscores the additive value of dietary sodium restriction in T2DM management.
Conclusion
The DASH4D randomized clinical trial provides compelling evidence that sodium reduction, with or without a diabetes-tailored DASH diet, yields significant and clinically relevant blood pressure decreases in adults with type 2 diabetes. These benefits were observed in a cohort largely treated with multiple antihypertensive medications, highlighting the practical potential of dietary interventions as adjuncts to pharmacological therapy. Future research should address long-term outcomes, implementation strategies, and expand inclusion to more diverse patient populations to maximize translational impact.
References
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 IF: 23.3 Q1 . PMID: 40489102 IF: 23.3 Q1 ; PMCID: PMC12150227 IF: 23.3 Q1 .
American Diabetes Association. Standards of Care in Diabetes—2024. Diabetes Care. 2024;47(Suppl. 1):S1-S350.
Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. J Am Coll Cardiol. 2018;71:e127-e248.
