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

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: L-Lysine
Drug: Normal Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT05210504
Lysine study #3

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

Participants administered oral lysine
Experimental group
Description:
participants will be administered 5g oral lysine
Treatment:
Drug: Normal Saline
Drug: L-Lysine

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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