Ignite Creation Date:
2024-05-06 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03063476
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2017-02-21
Brief Title:
The Effect of Acute Lysine Administration on α-aminoadipic Acid Sub-study
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
The Effect of Acute Lysine Administration on α-aminoadipic Acid
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 93 of the US population mortality burden 7th leading cause of death in the US and rising costs 245 billionyear 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 mgkgday 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
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 mgkgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None