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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
L-Lysine
Normal Saline
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring lysine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants administered oral lysine

Arm Description

participants will be administered 5g oral lysine

Outcomes

Primary Outcome Measures

Change in level of 2-AAA in plasma
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard.
Change in level of 2-AAA in urine
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2022
Last Updated
March 24, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05210504
Brief Title
Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 3
Official Title
Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 3
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
January 27, 2023 (Actual)
Study Completion Date
January 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
lysine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants administered oral lysine
Arm Type
Experimental
Arm Description
participants will be administered 5g oral lysine
Intervention Type
Drug
Intervention Name(s)
L-Lysine
Intervention Description
5g L-lysine in 50ml water, administered orally
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Normal (0.9%) Saline
Primary Outcome Measure Information:
Title
Change in level of 2-AAA in plasma
Description
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard.
Time Frame
Baseline to 6 Hours post-lysine administration
Title
Change in level of 2-AAA in urine
Description
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard.
Time Frame
Baseline to 6 Hours post-lysine administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Ferguson, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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