- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05210504
Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 3
March 24, 2023 updated by: Jane Ferguson, Vanderbilt University Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37212
- Vanderbilt University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participants administered oral lysine
participants will be administered 5g oral lysine
|
5g L-lysine in 50ml water, administered orally
Normal (0.9%) Saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in level of 2-AAA in plasma
Time Frame: Baseline to 6 Hours post-lysine administration
|
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard.
|
Baseline to 6 Hours post-lysine administration
|
Change in level of 2-AAA in urine
Time Frame: Baseline to 6 Hours post-lysine administration
|
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard.
|
Baseline to 6 Hours post-lysine administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jane Ferguson, PhD, Vanderbilt University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2022
Primary Completion (Actual)
January 27, 2023
Study Completion (Actual)
January 27, 2023
Study Registration Dates
First Submitted
January 13, 2022
First Submitted That Met QC Criteria
January 13, 2022
First Posted (Actual)
January 27, 2022
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
March 24, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lysine study #3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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