HealthyPhase 1NCT03063476
The Effect of Acute Lysine Administration on α-aminoadipic Acid (Sub-study)
A Phase 1 study testing C-13 labeled Lysine and Normal saline in people with Healthy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This sub-study aims to assess the effect and breakdown of lysine administration, specifically examining whether it leads to increased plasma 2-AAA in healthy humans. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- C-13 labeled Lysine and Normal saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 18 May 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18 to <25 kg/m2
- Men and women ages 18-45 years
Who cannot join
- Current use of prescription medications (apart from hormonal birth control)
- Current use of amino acid supplements (including branched-chain amino acids) or supplemental protein (habitual consumption of protein powder, bars, shakes), and unwilling to temporarily discontinue use (1 week prior to study visit)
- Individuals who currently use tobacco products or have done so in the previous 30 days
- Prior or current cardiovascular disease, renal disease, or liver disease
- Diabetes mellitus (taking insulin, other anti-diabetic agents, or diet-controlled)
- Atrial fibrillation
Show all 12Show fewer
- Bleeding disorder or anemia
- Positive pregnancy test
- Women who are breastfeeding
- Participation in another clinical trial within the previous 6 weeks prior to the study visit
- Inability to provide written informed consent
- Inability to fast for 8 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: The Effect of Acute Lysine Administration on α-aminoadipic Acid
This sub-study aims to assess the effect and breakdown of lysine administration, specifically examining whether it leads to increased plasma 2-AAA in healthy humans.
Read the detailed description
The significance of diabetes and related co-morbidities as considerable health concerns in the US and worldwide is clearly supported by the high incidence (estimated 9.3% of the US population), mortality burden (7th leading cause of death in the US), and rising costs ($245 billion/year). Strategies to identify individuals at high diabetic risk, and to modulate disease processes in these individuals before the onset of overt disease, would have a significant impact in reducing mortality, morbidity and healthcare costs. For this approach to be successful, early markers of disease that predict at-risk individuals before onset of dysregulated glycemic control are required, as well as discovering novel pathways for therapeutic targeting.
The purpose of the 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.
The investigators' specific aim is to determine whether acute lysine administration leads to increased plasma 2-AAA in humans. Catabolism of lysine leads to generation of 2-AAA. In this study, the investigators will determine whether a single dose of 13C isotope labeled lysine leads to increased plasma 2-AAA present in the blood and urine of humans. In this sub-study, the investigators will ask 2 lean, healthy subjects (preferably individuals who participated in a previous study visit) to drink a beverage containing C-13 labeled lysine and the investigators will measure the level of 2-AAA in their blood plasma and urine at baseline (before ingestion) and serially post-ingestion. The amount of lysine subjects will be given is equivalent to that which is found in a 5 oz. serving of beef. This sub-study will allow us to further establish and understand the relationship between lysine and 2-AAA in healthy subjects, and inform future studies on how to study the effects of 2-AAA on diabetes risk.
- Conditions
- Healthy
- Being tested
- C-13 labeled Lysine, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-13 labeled LysineDrug
Carbon-13 is a stable naturally occurring heavy isotope of carbon. Inclusion of a 13C label on lysine allows for subsequent differentiation between endogenous and exogenous lysine and 2-AAA for calculation of clearance and excretion of the lysine bolus.
Normal salineDrug
Also called Normal (0.9%) Saline (NS)
Because patients will have multiple blood draws during the course of the study, subjects will have an IV placed to reduce the number of needle sticks. To keep the vein open for blood collections, we will infuse Normal (0.9%) Saline (NS) at a rate of approximately 10ml/hr in order to keep the line open.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Two healthy subjects will be enrolled and each will undergo study procedures at one visit. After screening and consent have been conducted over the phone, subjects will participate in the study procedures. Subjects will arrive in a fasting state (no eat or drink for 8 hours, excluding water). Following collection of blood pressure, height, weight, and a urine and blood sample, subjects will be given an oral bolus of C-13 labeled lysine (5 g) in 50 ml water. This amount of lysine is equivalent to that which is found in a 5oz. serving of beef. Subjects will provide additional urine and blood samples serially post-ingestion. Because blood draws will be collected through an IV, Normal (0.9%) Saline (NS) will be infused at a rate of approximately 10 ml/hr to flush the canula prior to each blood draw.
All subjects will undergo the same procedures and interventions. Receives: Drug: C-13 labeled Lysine; Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma 2-AAA Concentration Percentage Change From Baseline
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified relative to standard.
Measured: Baseline and 2-6 hours
Secondary outcomes (1)
Peak Urinary 2-AAA Concentration Percentage Change From Baseline
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified relative to standard.
Measured: Baseline and 2-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 Mar 2017
- Primary completion18 May 2017
- Study completion18 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Ferguson, Vanderbilt University Medical Center
- Investigators
- Jane F Ferguson, PhD, Principal investigator, Vanderbilt Cardiovascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063476
- Sponsor's protocol ID
- 160520-1
- Status last verified
- Nov 2018
- First submitted
- 21 Feb 2017
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Lysine Administration on α-aminoadipic Acid
- ClinicalTrials.gov ID
- NCT03063476
- Acronym / sponsor ID
- 160520-1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 18 May 2017 (actual)
- Study completion
- 18 May 2017 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Posted 30 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This sub-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 significance of diabetes and related co-morbidities as considerable health concerns in the US and worldwide is clearly supported by the high incidence (estimated 9.3% of the US population), mortality burden (7th leading cause of death in the US), and rising costs ($245 billion/year). Strategies to identify individuals at high diabetic risk, and to modulate disease processes in these individuals before the onset of overt disease, would have a significant impact in reducing mortality, morbidity and healthcare costs. For this approach to be successful, early markers of disease that predict at-risk individuals before onset of dysregulated glycemic control are required, as well as discovering novel pathways for therapeutic targeting.
The purpose of the 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.
The investigators' specific aim is to determine whether acute lysine administration leads to increased plasma 2-AAA in humans. Catabolism of lysine leads to generation of 2-AAA. In this study, the investigators will determine whether a single dose of 13C isotope labeled lysine leads to increased plasma 2-AAA present in the blood and urine of humans. In this sub-study, the investigators will ask 2 lean, healthy subjects (preferably individuals who participated in a previous study visit) to drink a beverage containing C-13 labeled lysine and the investigators will measure the level of 2-AAA in their blood plasma and urine at baseline (before ingestion) and serially post-ingestion. The amount of lysine subjects will be given is equivalent to that which is found in a 5 oz. serving of beef. This sub-study will allow us to further establish and understand the relationship between lysine and 2-AAA in healthy subjects, and inform future studies on how to study the effects of 2-AAA on diabetes risk.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Drug: C-13 labeled Lysine, Drug: Normal salineTwo healthy subjects will be enrolled and each will undergo study procedures at one visit. After screening and consent have been conducted over the phone, subjects will participate in the study procedures. Subjects will arrive in a fasting state (no eat or drink for 8 hours, excluding water). Following collection of blood pressure, height, weight, and a urine and blood sample, subjects will be given an oral bolus of C-13 labeled lysine (5 g) in 50 ml water. This amount of lysine is equivalent to that which is found in a 5oz. serving of beef. Subjects will provide additional urine and blood samples serially post-ingestion. Because blood draws will be collected through an IV, Normal (0.9%) Saline (NS) will be infused at a rate of approximately 10 ml/hr to flush the canula prior to each blood draw. All subjects will undergo the same procedures and interventions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18 to <25 kg/m2
- Men and women ages 18-45 years
Key exclusion criteria (12 listed)
- Current use of prescription medications (apart from hormonal birth control)
- Current use of amino acid supplements (including branched-chain amino acids) or supplemental protein (habitual consumption of protein powder, bars, shakes), and unwilling to temporarily discontinue use (1 week prior to study visit)
- Individuals who currently use tobacco products or have done so in the previous 30 days
- Prior or current cardiovascular disease, renal disease, or liver disease
- Diabetes mellitus (taking insulin, other anti-diabetic agents, or diet-controlled)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-13 labeled LysineCarbon-13 is a stable naturally occurring heavy isotope of carbon. Inclusion of a 13C label on lysine allows for subsequent differentiation between endogenous and exogenous lysine and 2-AAA for calculation of clearance and excretion of the lysine bolus. | Drug | Healthy |
| Normal salineAlso: Normal (0.9%) Saline (NS)Because patients will have multiple blood draws during the course of the study, subjects will have an IV placed to reduce the number of needle sticks. To keep the vein open for blood collections, we will infuse Normal (0.9%) Saline (NS) at a rate of approximately 10ml/hr in order to keep the line open. | Drug | Healthy |
Primary outcome
Peak Plasma 2-AAA Concentration Percentage Change From Baseline
Time frame: Baseline and 2-6 hours
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified relative to standard.
1 secondary outcome
Peak Urinary 2-AAA Concentration Percentage Change From Baseline
Time frame: Baseline and 2-6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane F Ferguson, PhD principal investigator
Vanderbilt Cardiovascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C-13 labeled Lysine and Normal saline in people with Healthy, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma 2-AAA Concentration Percentage Change From Baseline (time frame: Baseline and 2-6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.