Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 3

NCT ID: NCT05210504

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2023-01-27

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Participants administered oral lysine

participants will be administered 5g oral lysine

Group Type: EXPERIMENTAL

L-Lysine

Intervention Type: DRUG

5g L-lysine in 50ml water, administered orally

Normal Saline

Intervention Type: DRUG

Normal (0.9%) Saline

Interventions

L-Lysine

5g L-lysine in 50ml water, administered orally

Intervention Type: DRUG

Normal Saline

Normal (0.9%) Saline

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jane Ferguson

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jane Ferguson, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Lysine study #3

Identifier Type: -

Identifier Source: org_study_id