连续血糖监测（CGM）研究在饮食方法停止高血压糖尿病试验（DASH4D-CGM）的设计。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-12 DOI:10.1016/j.cct.2025.107845

Dan Wang , Scott Z. Mu , Olive Tang , Justin B. Echouffo-Tcheugui , Christine M. Mitchell , Michael Fang , Mary R. Rooney , Hsin-Chieh Yeh , Casey M. Rebholz , Scott J. Pilla , Lawrence J. Appel , Elizabeth Selvin

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引用次数: 0

摘要

背景：饮食方法停止高血压（DASH）饮食是推荐给成人糖尿病患者。然而，DASH饮食对血糖控制和变异性的影响尚未得到充分研究。研究目的：研究改良DASH饮食对高血压和2型糖尿病患者血糖控制和血糖变异性的影响。方法：我们进行了一项辅助研究，将CGM添加到阻止糖尿病高血压的饮食方法（DASH4D）试验中。DASH4D试验旨在确定改良DASH饮食（相对于美国糖尿病患者的典型饮食）和降低钠摄入量（相对于高钠摄入量）对2型糖尿病和高血压患者收缩压的单独和联合影响。参与者按随机顺序连续5 周进食4种研究饮食。我们邀请所有参加DASH4D试验的参与者在筛选期间和四个5周喂养期中的每一个期间佩戴蒙面CGM传感器长达14 天。DASH4D-CGM研究的主要目的是评估改良DASH饮食（与对照饮食）对血糖控制（平均血糖和范围内时间）和葡萄糖变异性（变异系数）的影响。结论：结合CGM技术和控制饲养设计，DASH4D-CGM研究将获得关于饮食对血糖控制和变异性影响的可靠数据。这些发现将为成人2型糖尿病患者提供膳食建议。

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Design of the Continuous Glucose Monitoring (CGM) Study in the Dietary Approaches to Stop Hypertension for Diabetes Trial (DASH4D-CGM)

Background

The Dietary Approaches to Stop Hypertension (DASH) diet is recommended for adults with diabetes. However, the effects of the DASH diet on glucose control and variability have not been thoroughly investigated.

Study aim

To study the effects of a modified DASH diet on glycemic control and glucose variability assessed by continuous glucose monitoring (CGM) in individuals with hypertension and type 2 diabetes.

Methods

We conducted an ancillary study to add CGM to the Dietary Approaches to Stop Hypertension for Diabetes (DASH4D) Trial. The DASH4D Trial was designed to determine the effects, alone and combined, of a modified DASH diet (vs a diet typical of what Americans with diabetes eat) and lower (vs higher) sodium intake on systolic blood pressure among people with type 2 diabetes and elevated blood pressure. Participants were fed each of the 4 study diets for 5 weeks in a random order. We invited all participants enrolling in the DASH4D Trial to wear a masked CGM sensor for up to 14 days during screening and during each of the four 5-week feeding periods. The DASH4D-CGM Study primarily aimed to evaluate the effects of the modified DASH diet (vs comparison diet) on glycemic control (mean glucose and time-in-range) and glucose variability (coefficient of variation).

Conclusion

Combining CGM technology and a controlled feeding design, the DASH4D-CGM Study will generate robust data on the effects of diet on glycemic control and variability. These findings will inform dietary recommendations for adults with type 2 diabetes.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.