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

NCT05210504 | Completed Phase 1 Results FDA Drug

• 1 other identifier: Lysine study #3
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

lysine

Outcome Measures

Primary Outcomes (2)

• Change in Level of 13C 2-AAA in Plasma

  Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as the area under the curve from baseline to 6 hours post-lysine administration of isotope labeled 2-AAA.

  Baseline to 6 Hours post-lysine administration

• Change in Level of 2-AAA in Urine

  Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified to standard. The change was calculated as the total amount of 13C 2-AAA in micromoles excreted from Baseline to 6 hours.

  Baseline to 6 Hours post-lysine administration

Study Arms (1)

Participants administered oral lysine

EXPERIMENTAL

participants will be administered 5g oral lysine

Drug: L-Lysine; Drug: Normal Saline

Interventions

L-Lysine DRUG

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

Participants administered oral lysine

Normal Saline DRUG

Normal (0.9%) Saline

Participants administered oral lysine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Prior participant in 2-AAA Dietary study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Lysine; Saline Solution

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Jane Ferguson
• Organization: VUMC

jane.f.ferguson@vumc.org

6158759896

Study Officials

• Jane Ferguson, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 27, 2022
• Study Start: March 9, 2022
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: June 5, 2024
• Results First Posted: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)