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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05210504
• Other study ID #: Lysine study #3
• Status: Completed
• Phase: Phase 1
• Start date: March 9, 2022
• Est. completion date: January 27, 2023

Study information

• Verified date: March 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• L-Lysine
5g L-lysine in 50ml water, administered orally
• Normal Saline
Normal (0.9%) Saline

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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