Diabetes Mellitus, Type 2
Conditions
Keywords
lysine
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.
Interventions
DRUGL-Lysine
5g L-lysine in 50ml water, administered orally
DRUGNormal Saline
Normal (0.9%) Saline
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Level of 13C 2-AAA in Plasma | 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. |
| Change in Level of 2-AAA in Urine | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Participants Administered Oral Lysine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
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.
Time frame: Baseline to 6 Hours post-lysine administration
Population: One individual missed their baseline and 1Hr blood draws, and was omitted from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Administered Oral Lysine | Change in Level of 13C 2-AAA in Plasma | 1.742 uM*Hr | Standard Deviation 0.611 |
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.
Time frame: Baseline to 6 Hours post-lysine administration
Population: For one individual the volume of urine was not recorded, and their data could not be analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Administered Oral Lysine | Change in Level of 2-AAA in Urine | 7.69 Micromoles | Standard Deviation 4.25 |