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Completed

NCT Number: NCT05210504

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-lysine

Drug

5g L-lysine in 50ml water, administered orally

normal saline

Drug

Normal (0.9%) Saline

Primary outcomes

  1. Change in Level of 13C 2-AAA in Plasma

    Time frame: 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.

  2. Change in Level of 2-AAA in Urine

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2022
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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