Ignite Creation Date:
2024-05-06 @ 2:45 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04417218
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2020-06-02
Brief Title:
Determinants of Alpha-aminoadipic Acid 2-AAA and Relationship to Diabetes Study 2
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Determinants of Alpha-aminoadipic Acid 2-AAA and Relationship to Diabetes Study 2
Status:
COMPLETED
Status Verified Date:
2023-12
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 study aims to assess the effect of controlled dietary lysine intake on plasma and urine α-aminoadipic acid 2-AAA
Detailed Description:
Diabetes is an important health concern worldwide It is associated with significantly increased mortality as well as high incidence of co-morbidities Unfortunately treatment efficacy and successful disease management is highly variable among treated patients and this is partly due to the fact that diabetes has multiple underlying causes most of which are still unknown A newly identified biomarker α-aminoadipic acid 2-AAA has the potential to successfully predict the development of diabetes in humans even before the development of other known risk markers However little is known about the function of 2-AAA it is unclear whether 2-AAA itself causes the development of diabetes or if it is a biomarker for altered metabolic processes that then lead to diabetes
The aim of the first phase of the study was to measure plasma 2-AAA levels from healthy individuals from the general population to identify subjects with high or low 2-AAA Now in the second phase of the study 80 subjects with high or low 2-AAA will be invited to participate in a dietary lysine modification study to access the effect of controlled lysine intake on plasma and urine 2AAA Participants will be asked to complete two one-week dietary interventions Subjects will be screened and consented via email online or phone Each subject will be required to come to Vanderbilt University Medical Center for four study visits at which the study team will obtain a blood sample a urine sample stool sample vital signs waist and hip circumference and 1-3 surveys will be completed if the subject did not complete them prior to the visit Each subject that completes the entire study visit will be compensated 250 DNA samples will be obtained to allow for identification of genetic predictors of 2-AAA levels Some individuals may be asked to return for a future follow-up study
The aim of the first phase of the study was to measure plasma 2-AAA levels from healthy individuals from the general population to identify subjects with high or low 2-AAA Now in the second phase of the study 80 subjects with high or low 2-AAA will be invited to participate in a dietary lysine modification study to access the effect of controlled lysine intake on plasma and urine 2AAA Participants will be asked to complete two one-week dietary interventions Subjects will be screened and consented via email online or phone Each subject will be required to come to Vanderbilt University Medical Center for four study visits at which the study team will obtain a blood sample a urine sample stool sample vital signs waist and hip circumference and 1-3 surveys will be completed if the subject did not complete them prior to the visit Each subject that completes the entire study visit will be compensated 250 DNA samples will be obtained to allow for identification of genetic predictors of 2-AAA levels Some individuals may be asked to return for a future follow-up study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK117144 | NIH | None | httpsreporternihgovquickSearchR01DK117144 |