NCT05210504

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

Completed Phase 1 Results posted Last updated 5 June 2024

What this trial tests

Phase 1 trial testing L-Lysine in Diabetes Mellitus, Type 2 in 23 participants. Completed in 27 January 2023.

Timeline

9 March 2022

Primary endpoint
27 January 2023

27 January 2023

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	23
Start date	9 March 2022
Primary completion	27 January 2023
Estimated completion	27 January 2023
Sites	1 location across United States

Drugs / interventions tested

• L-Lysine (LYSINE) — full drug profile →
• Normal Saline

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 50, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Level of 13C 2-AAA in Plasma Primary · Baseline to 6 Hours post-lysine administration

Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as the area under the curve from baseline to 6 hours post-lysine administration of isotope labeled 2-AAA.

Group	Value	95% CI
Participants Administered Oral Lysine	1.742	± 0.611

Change in Level of 2-AAA in Urine Primary · Baseline to 6 Hours post-lysine administration

Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as the total amount of 13C 2-AAA in micromoles excreted from Baseline to 6 hours.

Group	Value	95% CI
Participants Administered Oral Lysine	7.69	± 4.25

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Response of Alpha-Aminoadipic Acid (2-AAA) to Short Term Lysine Ingestion in Healthy Individuals.
   Dean ED, Desine S, Smith HM, Doran AC, et al · · 2026 · PMID 41721626 · DOI 10.1002/edm2.70168