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临床试验/NCT04417218
NCT04417218已完成不适用

Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2020年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
2
主要终点
Change in Plasma 2-AAA Concentration From Baseline

研究概览

简要总结

This study aims to assess the effect of controlled dietary lysine intake on plasma and urine α-aminoadipic acid (2-AAA).

详细描述

Diabetes is an important health concern worldwide. It is associated with significantly increased mortality as well as high incidence of co-morbidities. Unfortunately, treatment efficacy and successful disease management is highly variable among treated patients, and this is partly due to the fact that diabetes has multiple underlying causes most of which are still unknown. A newly identified biomarker, α-aminoadipic acid (2-AAA), has the potential to successfully predict the development of diabetes in humans, even before the development of other known risk markers. However, little is known about the function of 2-AAA; it is unclear whether 2-AAA itself causes the development of diabetes or if it is a biomarker for altered metabolic processes that then lead to diabetes.

The aim of the first phase of the study was to measure plasma 2-AAA levels from healthy individuals from the general population to identify subjects with high or low 2-AAA. Now in the second phase of the study, 80 subjects with high or low 2-AAA will be invited to participate in a dietary lysine modification study to access the effect of controlled lysine intake on plasma and urine 2AAA. Participants will be asked to complete two one-week dietary interventions. Subjects will be screened and consented via email, online, or phone. Each subject will be required to come to Vanderbilt University Medical Center for four study visits, at which the study team will obtain a blood sample, a urine sample, stool sample, vital signs, waist and hip circumference, and 1-3 surveys will be completed if the subject did not complete them prior to the visit. Each subject that completes the entire study visit will be compensated $250. DNA samples will be obtained to allow for identification of genetic predictors of 2-AAA levels. Some individuals may be asked to return for a future follow-up study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Prior participant in 2-AAA screening study.
  • Identified as eligible due to high or low plasma 2-AAA, in the absence of hyperglycemia, as defined by study team.

排除标准

  • Individuals who currently use tobacco products.
  • Use of prescription or over-the-counter medications or dietary supplements which could modulate levels of 2-AAA and unwilling to discontinue use (from 24 hours prior to first study visit until completion of study). Hormonal birth control is acceptable.
  • Follow a severely restricted diet or have food allergies, which would preclude adherence to study diet.
  • Newly diagnosed disease (since screening visit), including cardiovascular, renal, or 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

结局指标

主要结局

Change in Plasma 2-AAA Concentration From Baseline

时间窗: Change from pre-diet to post-diet (1 week)

Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as post-diet minus pre-diet for each Intervention (Normal lysine and High lysine).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jane Ferguson

Assistant Professor, Cardiovascular Medicine Division

Vanderbilt University Medical Center

研究点 (2)

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