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阻止糖尿病高血压的饮食方法 (DASH4D)

2026年4月21日 更新者：Johns Hopkins University

糖尿病试验中停止高血压的饮食方法

DASH4D 试验的目的是确定 (a) DASH4D 饮食（一种针对糖尿病患者改良的 DASH 式饮食）与许多美国人典型饮食的比较饮食（b ) 较低的钠摄入量与较高的钠摄入量对血压 (BP) 的影响。 核心设计是单点、4 周期、5 周周期的交叉喂养研究。 参与者被喂食四种等热量饮食中的每一种，以随机顺序呈现。 感兴趣的主要对比是低钠的 DASH4D 饮食与高钠的比较饮食。

研究概览

地位

完全的

条件

干预/治疗

详细说明

无论是否患有糖尿病，血压升高 (BP) 都是中风的主要原因，也是其他心血管疾病（包括冠心病和心力衰竭）的主要危险因素。 有效降低血压的策略包括药物治疗和改变生活方式。 生活方式的改变，特别是饮食方法，已被证明可以降低非糖尿病患者的血压。 然而，除了减肥之外，关于糖尿病患者降压、生活方式改变的证据非常缺乏。 DASH4D 试验旨在提供这一证据。

DASH4D 试验以研究人员在 NIH 赞助的四项喂养研究（DASH、DASH-Sodium、OmniHeart 和 OmniCarb）中的经验为基础。 该试验将招募大约 100 名患有 2 型糖尿病、收缩压 120-159 mmHg 和舒张压的成年人

核心设计是一个为期 5 周的四期单点交叉喂养研究。 参与者被喂食四种等热量饮食中的每一种，以随机顺序呈现：

  1. DASH4D 低钠饮食
  2. DASH4D 高钠饮食
  3. 比较低钠饮食
  4. 比较高钠饮食。

感兴趣的主要对比是低钠的 DASH4D 饮食与高钠的比较饮食。

DASH4D 饮食与原始 DASH 饮食相似，但碳水化合物含量低于原始 DASH 饮食，不饱和脂肪含量较高，因此与原始 DASH 饮食相比，更符合糖尿病患者的饮食建议。 比较饮食反映了许多糖尿病患者目前的饮食。 大约 1500 毫克/天（2000 千卡）的较低钠摄入量已被证明可以降低非糖尿病患者的血压，并且已在一些饮食指南中推荐。 大约 3700 毫克/天（2000 大卡）的较高钠摄入量是根据美国估计的平均摄入量得出的。

在每个喂养期结束时测量结果。 主要结果是期末基于诊室的收缩压。 其他结果是舒张压、血糖测量、血脂危险因素、患者症状和估计的心血管疾病风险。

与研究人员之前的喂养研究类似，研究人员预计 DASH4D 试验的结果将立即适用于公共卫生和临床指南，并将影响营养政策。 此外，该试验将提供一个严格的平台来评估饮食和钠摄入量对 2 型糖尿病患者各种其他结果的影响。

研究类型

介入性

注册 (实际的)

105

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Maryland
      • Baltimore、Maryland、美国、21207
        • Johns Hopkins ProHealth

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 年满 18 岁
  • 由 HbA1c ≥6.5% 定义的 2 型糖尿病或使用糖尿病药物治疗糖尿病
  • 基线收缩压为 120-159 mmHg（基于 3 次筛查访视的平均值）
  • 基线舒张压
  • 愿意并能够在现场进食，每天一顿饭，每周 3 天，并且在受控喂养期间（磨合期和四个 5 周喂养期）只吃和作为研究饮食的一部分提供的所有食物。 请注意，由于 COVID 相关限制，现场用餐的实际频率可能会少于每周 3 天，但参与者仍然需要每周 3 天在现场取餐和称重，并且仍将被期望每周 3 天，每天一餐（面对面或远程）进行膳食监控。
  • 愿意并能够完成规定的测量程序
  • 可以使用具有视频会议功能的移动设备或计算机，或愿意使用研究提供的视频会议设备

排除标准：

  • 实验室排除

    • 血清钾≥5.2 mmol/L 或
    • 估计肾小球滤过率 (eGFR)
    • HbA1c>9.0%

  • 药物排除

    1. 以下任何一项的剂量不稳定（即在筛选前或随机化前 2 个月内发生变化）：

      • 抗高血压药物
      • 钠-葡萄糖协同转运蛋白 2 (SGLT2) 抑制剂或胰高血糖素样肽-1 (GLP-1) 受体激动剂
      • 兴奋剂，包括用于治疗哮喘或慢性阻塞性肺病 (COPD) 的口服药物
      • 激素替代疗法或甲状腺激素
      • 增加体重的精神药物，包括抗精神病药、锂和米氮平

    2. 使用以下任何药物：

      • 钾补充剂，除非是复合维生素的一部分
      • 餐时或短效胰岛素
      • GLP-1 受体激动剂（如果服用减肥剂量）
      • 华法林（香豆素）
      • 慢性口服皮质类固醇（间歇性使用是可以的）
      • 减肥药
    3. 不愿意保持相同剂量的维生素、矿物质和植物补充剂
    4. 研究人员确定与参与不相容的任何药物

  • 病史排除

    • 1型糖尿病
    • 在过去 12 个月内需要住院治疗或需要他人协助的低血糖症
    • 活动性心血管疾病或前 6 个月内发生的任何事件，包括冠状动脉旁路移植术 (CABG)、经皮腔内冠状动脉成形术 (PTCA)、心肌梗死 (MI)、脑血管意外 (CVA) 或充血性心力衰竭 (CHF) 恶化需要入院
    • 最近 2 年的癌症诊断或治疗（非黑色素瘤皮肤癌或局部乳腺癌或前列腺癌不需要全身治疗是可以接受的）
    • 活动性炎症性肠病、肠切除术、吸收不良综合征、胰腺炎（过去一年内发作）或减肥手术史
    • 怀孕或哺乳或计划怀孕
    • 在过去 6 个月内因哮喘或慢性阻塞性肺病 (COPD) 到急诊科 (ED) 就诊
    • 研究人员确定的与参与不相容的任何其他严重疾病或状况

  • 物理排除

    • 体重 >420 磅
    • 臂围≥50cm
    • 前 2 个月体重减轻或增加超过体重的 5.0%

  • 生活方式和其他除外责任

    • 严重的食物过敏、偏好、不耐受或饮食要求会影响饮食依从性
    • 如果需要，无法自我监测血糖
    • 每周饮用超过 14 杯酒精饮料或每周一次或多次饮用超过 6 杯酒精饮料
    • 会干扰参与的活性物质使用障碍
    • 参与或计划开始减肥计划
    • 目前参加另一项临床试验
    • 计划在学习结束前离开区域
    • 调查员自由裁量权

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：DASH4D 低钠饮食
DASH 式饮食模式，针对糖尿病患者进行了改良，钠含量为 1500 毫克/天
其他：DASH4D饮食
DASH 代表“停止高血压的饮食方法”。 DASH 饮食是一种可以降低血压的健康节食法。 DASH 饮食强调水果、蔬菜和低脂乳制品；包括全麦、家禽、鱼和坚果；在红肉、糖果和含糖饮料中减少。 DASH4D 饮食模式是碳水化合物含量较低的 DASH 饮食的一个版本。
其他：低钠
1500 毫克/天钠（2000 千卡水平）
有源比较器：DASH4D 高钠饮食
DASH 式饮食模式，针对糖尿病患者进行了修改，钠含量为 3700 毫克/天
其他：DASH4D饮食
DASH 代表“停止高血压的饮食方法”。 DASH 饮食是一种可以降低血压的健康节食法。 DASH 饮食强调水果、蔬菜和低脂乳制品；包括全麦、家禽、鱼和坚果；在红肉、糖果和含糖饮料中减少。 DASH4D 饮食模式是碳水化合物含量较低的 DASH 饮食的一个版本。
其他：高钠
3700 毫克/天钠（2000 千卡水平）
有源比较器：低钠饮食比较
许多美国人糖尿病患者的典型饮食模式，钠含量为 1500 毫克/天
其他：比较饮食
比较饮食模式基于典型的美国饮食，大量营养素分布通常处于典型美国摄入量的平均值，微量营养素目标通常接近美国通常摄入量的第 25 个百分位数（钠除外）。
其他：低钠
1500 毫克/天钠（2000 千卡水平）
其他：比较高钠饮食
许多美国人糖尿病患者的典型饮食模式，钠含量为 3700 毫克/天
其他：比较饮食
比较饮食模式基于典型的美国饮食，大量营养素分布通常处于典型美国摄入量的平均值，微量营养素目标通常接近美国通常摄入量的第 25 个百分位数（钠除外）。
其他：高钠
3700 毫克/天钠（2000 千卡水平）

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Systolic Blood Pressure (SBP)
大体时间：At the end of 5-week feeding period
After the participant has rested quietly in the seated position for at least 5 minutes, blood pressure will be measured in triplicate, using an Omron device, with each reading separated by 30 seconds, and the average of the three readings (in mmHg) will also be recorded. Blood pressure will be measured on five separate occasions during the last 2 weeks of the feeding period, and the mean systolic blood pressure from these five blood pressures (15 total readings) will be used as the primary outcome.
At the end of 5-week feeding period

次要结果测量

结果测量
措施说明
大体时间
Diastolic Blood Pressure (DBP)
大体时间：At the end of 5-week feeding period
After the participant has rested quietly in the seated position for at least 5 minutes, blood pressure will be measured in triplicate, using an Omron device, with each reading separated by 30 seconds, and the average of the three readings (in mmHg) will also be recorded. Blood pressure will be measured on five separate occasions during the last 2 weeks of the feeding period, and the mean diastolic blood pressure from these five blood pressures (15 total readings) will be used as a secondary outcome.
At the end of 5-week feeding period

其他结果措施

结果测量
措施说明
大体时间
Glycated Albumin Level
大体时间：At the end of 5-week feeding period
Glycated albumin percentage (%).
At the end of 5-week feeding period
Fructosamine Level
大体时间：At the end of 5-week feeding period
Fructosamine level in mmol/L.
At the end of 5-week feeding period
Fasting Glucose Level
大体时间：At the end of 5-week feeding period
Fasting glucose level in mg/dL.
At the end of 5-week feeding period
Hemoglobin A1c (HbA1c) Level
大体时间：At the end of 5-week feeding period
HbA1c percentage (%).
At the end of 5-week feeding period
Cardiovascular Disease (CVD) Risk Percentage
大体时间：At the end of 5-week feeding period
Current 10-year atherosclerotic cardiovascular disease (ASCVD) risk will be reported as a percent, using the American College of Cardiology (ACC)/American Heart Association (AHA) ASCVD risk equation.
At the end of 5-week feeding period
Total Cholesterol Level
大体时间：At the end of 5-week feeding period
Total cholesterol level in mg/dL.
At the end of 5-week feeding period
Low-density Lipoprotein (LDL) Cholesterol Level
大体时间：At the end of 5-week feeding period
LDL cholesterol level in mg/dL.
At the end of 5-week feeding period
High-density Lipoprotein (HDL) Cholesterol Level
大体时间：At the end of 5-week feeding period
HDL cholesterol level in mg/dL.
At the end of 5-week feeding period
Triglyceride Level
大体时间：At the end of 5-week feeding period
Triglyceride level in mg/dL.
At the end of 5-week feeding period
Presence of Orthostatic Hypotension
大体时间：At the end of 5-week feeding period
Participants will lie in the supine position for 5 minutes and undergo three blood pressure measurements, separated by 30 seconds. The average of these three readings will be used as the supine blood pressure. Participants will stand with their arm rested on an adjacent Mayo table at 70-80 degrees from their torso, and participants will then undergo another set of triplicate blood pressure measurements, separated by 30 seconds each. The average of these three readings will be used as the standing blood pressure. Presence of orthostatic hypotension will be defined as ≥ 20 mmHg drop in systolic blood pressure or a ≥ 10 mmHg drop in diastolic blood pressure upon standing.
At the end of 5-week feeding period
Postural Change in Systolic Blood Pressure
大体时间：At the end of 5-week feeding period
Participants will lie in the supine position for 5 minutes and undergo three blood pressure measurements, separated by 30 seconds. The average of these three readings will be used as the supine blood pressure. Participants will stand with their arm rested on an adjacent Mayo table at 70-80 degrees from their torso, and participants will then undergo another set of triplicate blood pressure measurements, separated by 30 seconds each. The average of these three readings will be used as the standing blood pressure. Change in systolic blood pressure (mmHg) upon standing will be calculated.
At the end of 5-week feeding period
Postural Change in Diastolic Blood Pressure
大体时间：At the end of 5-week feeding period
Participants will lie in the supine position for 5 minutes and undergo three blood pressure measurements, separated by 30 seconds. The average of these three readings will be used as the supine blood pressure. Participants will stand with their arm rested on an adjacent Mayo table at 70-80 degrees from their torso, and participants will then undergo another set of triplicate blood pressure measurements, separated by 30 seconds each. The average of these three readings will be used as the standing blood pressure. Change in diastolic blood pressure (mmHg) upon standing will be calculated.
At the end of 5-week feeding period
Symptoms Experienced by Participants as Assessed by a Questionnaire
大体时间：At the end of 5-week feeding period
Participants will complete a questionnaire about symptoms experienced while on each diet, including symptoms related to fall risk (e.g., feeling faint), food intake and output (e.g., bloating, constipation), fluid intake and output (e.g., excessive thirst), and general symptoms (e.g., fatigue or low energy). Participants will be asked to rate each listed symptom as: did not occur, mild, moderate, or severe. Score range 0-69, higher score worse symptoms.
At the end of 5-week feeding period
Mean Continuous Glucose Monitoring Sensor Glucose
大体时间：14-day wear period during weeks 3-5
CGM Ancillary Study Primary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The mean of these glucose measurements (in mg/dL) during the 14-day wear period will be used as a primary outcome of the corresponding feeding period.
14-day wear period during weeks 3-5
Percentage of Time Glucose Between 70 and 180 mg/dL
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Primary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was between 70 and 180 mg/dL (time-in-range) during 14-day wear period will be used as a primary outcome of the corresponding feeding period.
At the end of 5-week feeding period
Glucose Coefficient of Variation (%)
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Primary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The glucose coefficient of variation (standard deviation divided by mean glucose, multiplied by 100 and expressed as a percent) during the 14-day wear period will be used as a primary outcome of the corresponding feeding period.
At the end of 5-week feeding period
Glucose Standard Deviation
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The standard deviation of glucose measurements (in mg/dL) will be used as a secondary outcome of the corresponding feeding period.
At the end of 5-week feeding period
Percentage of Time Glucose Above 180 mg/dL
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was above 180 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period.
At the end of 5-week feeding period
Percentage of Time Glucose Above 250 mg/dL
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was above 250 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period.
At the end of 5-week feeding period
Percentage of Time Glucose Below 70 mg/dL
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was below 70 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period.
At the end of 5-week feeding period
Percentage of Time Glucose Below 54 mg/dL
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was below 54 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period.
At the end of 5-week feeding period
Percentage of Time Glucose Between 70 to 140 mg/dL
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was between 70 and 140 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
At the end of 5-week feeding period
Percentage of Time Glucose Above 140 mg/dL
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was above 140 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
At the end of 5-week feeding period
Proportion of Participants With >70% Time Glucose Between 70 to 180 mg/dL
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent >70% of time with glucose between 70 and 180 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
At the end of 5-week feeding period
Proportion of Participants With Glucose Coefficient of Variation <36%
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants with a glucose coefficient of variation <36% during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
At the end of 5-week feeding period
Proportion of Participants With <25% Time Glucose Above 180 mg/dL
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent <25% of time with glucose above 180 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
At the end of 5-week feeding period
Proportion of Participants With <5% Time Glucose Above 250 mg/dL
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent <5% of time with glucose above 250 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
At the end of 5-week feeding period
Proportion of Participants With <4% Time Glucose Below 70 mg/dL
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent <4% of time with glucose below 70 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
At the end of 5-week feeding period
Proportion of Participants With <1% Time Glucose Below 54 mg/dL
大体时间：At the end of 5-week feeding period
CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent <1% of time with glucose below 54 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period.
At the end of 5-week feeding period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Johns Hopkins University

合作者

University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Beth Israel Deaconess Medical Center
Sheikh Khalifa Stroke Institute at Johns Hopkins

调查人员

  • 首席研究员：Lawrence Appel, MD, MPH、Johns Hopkins University
  • 首席研究员：Hsin Chieh Yeh, PhD、Johns Hopkins University
  • 首席研究员：Scott Pilla, MD, MHS、Johns Hopkins University
  • 首席研究员：Elizabeth Selvin, PhD、Johns Hopkins University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年6月2日

初级完成 (实际的)

2024年6月13日

研究完成 (实际的)

2024年6月17日

研究注册日期

首次提交

2020年2月25日

首先提交符合 QC 标准的

2020年2月25日

首次发布 (实际的)

2020年2月27日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年4月21日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB00232059
  • R01DK128900 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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