Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 3
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in Level of 2-AAA in Urine
研究概览
简要总结
This study aims to assess the effect and breakdown of lysine administration, specifically examining whether it leads to increased plasma 2-AAA in healthy humans.
详细描述
The purpose of this study is to investigate a novel biomarker, α-aminoadipic acid (2-AAA), which may influence the risk of diabetes. 2-AAA has been identified as a novel predictor of diabetes development in humans, identifying at-risk individuals before any detectable glucose abnormalities. 2-AAA is a naturally occurring metabolite in the body, and it has no known adverse effects at normal physiological levels. 2-AAA is generated in the body from the breakdown of lysine. Lysine is one of the twenty essential amino acids, meaning that it is essential for human function, but that our body cannot manufacture it. Thus, it is acquired from dietary sources (such as meat, eggs, soybeans and legumes), with a recommended daily intake of 30 mg/kg/day. Amino acids are the building blocks of proteins, which are what allow our cells, organs and body to maintain structure and function. The investigators are interested in whether 2-AAA is increased in the body after consumption of lysine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Prior participant in 2-AAA Dietary study.
排除标准
- •Newly diagnosed disease, including cardiovascular, renal, liver disease, or Diabetes mellitus.
- •Individuals who are pregnant or lactating.
- •Inability to provide written or electronic informed consent.
- •Inability to fast for 8 hours.
研究组 & 干预措施
Participants administered oral lysine
participants will be administered 5g oral lysine
干预措施: L-Lysine (Drug)
Participants administered oral lysine
participants will be administered 5g oral lysine
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change in Level of 2-AAA in Urine
时间窗: Baseline to 6 Hours post-lysine administration
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as the total amount of 13C 2-AAA in micromoles excreted from Baseline to 6 hours.
Change in Level of 13C 2-AAA in Plasma
时间窗: Baseline to 6 Hours post-lysine administration
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as the area under the curve from baseline to 6 hours post-lysine administration of isotope labeled 2-AAA.
次要结局
未报告次要终点
研究者
Jane Ferguson
Associate Professor of Medicine
Vanderbilt University Medical Center