Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 3

Phase 1

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

-Prior participant in 2-AAA Dietary study.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Participants administered oral lysine	Normal Saline	participants will be administered 5g oral lysine
Participants administered oral lysine	L-Lysine	participants will be administered 5g oral lysine

Primary Outcome Measures

Name	Time	Method
Change in Level of 2-AAA in Urine	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	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.

Secondary Outcome Measures