NCT05210504

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	L-Lysine	5g L-lysine in 50ml water, administered orally
DRUG	Normal Saline	Normal (0.9%) Saline

Timeline

• Start date: 2022-03-09
• Primary completion: 2023-01-27
• Completion: 2023-01-27
• First posted: 2022-01-27
• Last updated: 2024-06-05
• Results posted: 2024-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study