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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants administered oral lysine | Experimental | participants will be administered 5g oral lysine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Lysine | Drug | 5g L-lysine in 50ml water, administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Level of 13C 2-AAA in Plasma | 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. | Baseline to 6 Hours post-lysine administration |
| Change in Level of 2-AAA in Urine | 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. | Baseline to 6 Hours post-lysine administration |
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Inclusion Criteria:
-Prior participant in 2-AAA Dietary study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Ferguson, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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We enrolled 23 individuals to the study. 4 individuals withdrew before the start of the study due to scheduling conflicts, and 2 individuals were lost to follow up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Administered Oral Lysine | participants will be administered 5g oral lysine L-Lysine: 5g L-lysine in 50ml water, administered orally Normal Saline: Normal (0.9%) Saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All individuals are analyzed where possible. One participant did not provide a baseline blood draw, and was excluded from the analysis for plasma measurements.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Administered Oral Lysine | Participants will be administered 5g oral lysine L-Lysine: 5g L-lysine in 50ml water, administered orally Normal Saline: Normal (0.9%) Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Level of 13C 2-AAA in Plasma | 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. | One individual missed their baseline and 1Hr blood draws, and was omitted from the analysis. | Posted | Mean | Standard Deviation | uM*Hr | Baseline to 6 Hours post-lysine administration |
|
Data were collected throughout the 6 hour study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Administered Oral Lysine | participants will be administered 5g oral lysine L-Lysine: 5g L-lysine in 50ml water, administered orally Normal Saline: Normal (0.9%) Saline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jane Ferguson | VUMC | 6158759896 | jane.f.ferguson@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2022 | Dec 20, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2022 | Mar 24, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008239 | Lysine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Normal Saline |
| Drug |
Normal (0.9%) Saline |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Change in Level of 2-AAA in Urine | 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. | For one individual the volume of urine was not recorded, and their data could not be analyzed. | Posted | Mean | Standard Deviation | Micromoles | Baseline to 6 Hours post-lysine administration |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D004700 | Endocrine System Diseases |
| D000601 | Amino Acids, Essential |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |