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

December 20, 2023 updated by: Jane Ferguson, Vanderbilt University Medical Center
This study aims to assess the effect of controlled dietary lysine intake on plasma and urine α-aminoadipic acid (2-AAA).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Normal Lysine Diet
Participants will complete two one-week dietary interventions, in a randomized order. For the normal lysine diet, participants will be asked to adhere to a specific diet for 1 week. Each study subject will receive 3 meals and 1-2 snacks per day during the study period.
Dietary supplement: Controlled Diet
Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.
Experimental: High Lysine Diet
Participants will complete two one-week dietary interventions, in a randomized order. For the high lysine diet, participants will be asked to consume the same foods as in the normal lysine diet, but with the addition of lysine supplements (5g/day).
Dietary supplement: Controlled Diet
Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.
Dietary supplement: Lysine
Lysine is an essential amino acid which is acquired from dietary sources.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Plasma 2-AAA Concentration From Baseline
Time Frame: Change from pre-diet to post-diet (1 week)
Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as post-diet minus pre-diet for each Intervention (Normal lysine and High lysine).
Change from pre-diet to post-diet (1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200427
  • R01DK117144 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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