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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05210504

Collaborator

(none)

Enrollment

Location

Arm

21.8

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: L-Lysine Drug: Normal Saline	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 9, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Participants administered oral lysine

participants will be administered 5g oral lysine

Drug: L-Lysine

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

Drug: Normal Saline

Normal (0.9%) Saline

Outcome Measures

Primary Outcome Measures

Change in level of 2-AAA in plasma [Baseline to 6 Hours post-lysine administration]
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard.
Change in level of 2-AAA in urine [Baseline to 6 Hours post-lysine administration]
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

Principal Investigator: Jane Ferguson, PhD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jane Ferguson, Associate Professor of Medicine, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT05210504

Other Study ID Numbers:

Lysine study #3

First Posted:

Jan 27, 2022

Last Update Posted:

Mar 28, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Jane Ferguson, Associate Professor of Medicine, Vanderbilt University Medical Center

lysine

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 28, 2022