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Background <p>Chronic kidney disease (CKD) is an increasingly prevalent disease that adversely affects patients’ quality of life and medical expenses. While its progression is linked to lifestyle-related diseases, its association with dyslipidemia remains unclear. We previously showed a significant association between a high triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) ratio and CKD progression and cardiovascular disease in CKD patients. Recent reports indicate that D-alanine regulates circadian rhythms, participates in gluconeogenesis, and exhibits renoprotective effects. This study will investigate whether D-alanine has a beneficial effect on the TG/HDL-C ratio in CKD patients.</p> Methods <p>This open-label, multicenter, single-arm, exploratory trial will involve 20 CKD patients and last for 10 weeks, including a 2-week run-in, 4-week treatment, and 4-week follow-up period. Patients will be recruited from Nara Medical University and Nara Prefectural General Medical Center. The primary endpoint is the change in fasting TG/HDL-C ratios between baseline and Day 28. Secondary endpoints include changes in fasting TG, HDL-C, low-density lipoprotein cholesterol, aspartate aminotransferase, alanine aminotransferase, glycated hemoglobin A1c, systolic and diastolic blood pressure, proteinuria, estimated glomerular filtration rate, and body weight between baseline and Day 28. The study will summarize absolute measurements and changes using descriptive statistics, confidence intervals, and line graphs showing means ± confidence intervals. A two-tailed significance level of <i>p</i> &lt; 0.05 will be used.</p> Discussion <p>This exploratory study aims to evaluate the efficacy and safety of D-alanine for treating dyslipidemia in CKD patients, and may provide insights that help reduce the risk of cardiorenal events in CKD patients.</p> Trial registration <p>This protocol was approved by the Clinical Trial Review Board of Nara Medical University Clinical Research Review Committee (CRB5200002) on February 5, 2025, and is available to the public on the website of the Japan Registry of Clinical Trials on December 18, 2024 (jRCTs051240262).</p>

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Design and rationale for a pilot trial of D-alanine supplementation to reduce the triglyceride to high-density lipoprotein cholesterol ratio in patients with chronic kidney disease

  • 期刊论文

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  • 发表日期：

    2025年11月24日

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  • Masaru Matsui,
  • Masatoshi Nishimoto,
  • Takayuki Uemura,
  • Shunsuke Kitamura,
  • Wasako Tato,
  • Hideo Tsushima,
  • Takaaki Kosugi,
  • Masahiro Eriguchi,
  • Ken-ichi Samejima,
  • Masashi Mita,
  • Masato Kasahara,
  • Kazuhiko Tsuruya

摘要

Background

Chronic kidney disease (CKD) is an increasingly prevalent disease that adversely affects patients’ quality of life and medical expenses. While its progression is linked to lifestyle-related diseases, its association with dyslipidemia remains unclear. We previously showed a significant association between a high triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) ratio and CKD progression and cardiovascular disease in CKD patients. Recent reports indicate that D-alanine regulates circadian rhythms, participates in gluconeogenesis, and exhibits renoprotective effects. This study will investigate whether D-alanine has a beneficial effect on the TG/HDL-C ratio in CKD patients.

Methods

This open-label, multicenter, single-arm, exploratory trial will involve 20 CKD patients and last for 10 weeks, including a 2-week run-in, 4-week treatment, and 4-week follow-up period. Patients will be recruited from Nara Medical University and Nara Prefectural General Medical Center. The primary endpoint is the change in fasting TG/HDL-C ratios between baseline and Day 28. Secondary endpoints include changes in fasting TG, HDL-C, low-density lipoprotein cholesterol, aspartate aminotransferase, alanine aminotransferase, glycated hemoglobin A1c, systolic and diastolic blood pressure, proteinuria, estimated glomerular filtration rate, and body weight between baseline and Day 28. The study will summarize absolute measurements and changes using descriptive statistics, confidence intervals, and line graphs showing means ± confidence intervals. A two-tailed significance level of p < 0.05 will be used.

Discussion

This exploratory study aims to evaluate the efficacy and safety of D-alanine for treating dyslipidemia in CKD patients, and may provide insights that help reduce the risk of cardiorenal events in CKD patients.

Trial registration

This protocol was approved by the Clinical Trial Review Board of Nara Medical University Clinical Research Review Committee (CRB5200002) on February 5, 2025, and is available to the public on the website of the Japan Registry of Clinical Trials on December 18, 2024 (jRCTs051240262).