Phase 1
N=17
Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 3
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT05210504 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change in Level of 13C 2-AAA in Plasma — 1.742 uM*Hr
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- L-Lysine (Drug); Normal Saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Level of 13C 2-AAA in Plasma |
1.742 | — |
| PRIMARY Change in Level of 2-AAA in Urine |
7.69 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05210504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.