Status:
COMPLETED
Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Prior participant in 2-AAA screening study.
- Identified as eligible due to high or low plasma 2-AAA, in the absence of hyperglycemia, as defined by study team.
Exclusion
- Individuals who currently use tobacco products.
- Use of prescription or over-the-counter medications or dietary supplements which could modulate levels of 2-AAA and unwilling to discontinue use (from 24 hours prior to first study visit until completion of study). Hormonal birth control is acceptable.
- Follow a severely restricted diet or have food allergies, which would preclude adherence to study diet.
- Newly diagnosed disease (since screening visit), including cardiovascular, renal, or 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
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04417218
Start Date
August 17 2020
End Date
January 1 2023
Last Update
December 21 2023
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212