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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: L-Lysine
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants administered oral lysine<br>participants will be administered 5g oral lysine | Drug: L-Lysine<br>* 5g L-lysine in 50ml water, administered orally<br>Drug: Normal Saline<br>* Normal (0.9%) Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of 2-AAA in plasma | Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. | Baseline to 6 Hours post-lysine administration | 
| Change in level of 2-AAA in urine | Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. | Baseline to 6 Hours post-lysine administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lysine