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Trial Outcomes & Findings for Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 3 (NCT NCT05210504)

NCT ID: NCT05210504

Last Updated: 2024-06-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

23 participants

Primary outcome timeframe

Baseline to 6 Hours post-lysine administration

Results posted on

2024-06-05

Participant Flow

We enrolled 23 individuals to the study. 4 individuals withdrew before the start of the study due to scheduling conflicts, and 2 individuals were lost to follow up.

Participant milestones

Participant milestones
Measure
Participants Administered Oral Lysine
participants will be administered 5g oral lysine L-Lysine: 5g L-lysine in 50ml water, administered orally Normal Saline: Normal (0.9%) Saline
Overall Study
STARTED
17
Overall Study
COMPLETED
17
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Participants Administered Oral Lysine
n=17 Participants
Participants will be administered 5g oral lysine L-Lysine: 5g L-lysine in 50ml water, administered orally Normal Saline: Normal (0.9%) Saline
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
n=93 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
Sex: Female, Male
Female
14 Participants
n=93 Participants
Sex: Female, Male
Male
3 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
1 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=93 Participants
Race (NIH/OMB)
White
15 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Region of Enrollment
United States
17 participants
n=93 Participants

PRIMARY outcome

Timeframe: Baseline to 6 Hours post-lysine administration

Population: One individual missed their baseline and 1Hr blood draws, and was omitted from the analysis.

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.

Outcome measures

Outcome measures
Measure
Participants Administered Oral Lysine
n=16 Participants
participants will be administered 5g oral lysine L-Lysine: 5g L-lysine in 50ml water, administered orally Normal Saline: Normal (0.9%) Saline
Change in Level of 13C 2-AAA in Plasma
1.742 uM*Hr
Standard Deviation 0.611

PRIMARY outcome

Timeframe: Baseline to 6 Hours post-lysine administration

Population: For one individual the volume of urine was not recorded, and their data could not be analyzed.

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.

Outcome measures

Outcome measures
Measure
Participants Administered Oral Lysine
n=16 Participants
participants will be administered 5g oral lysine L-Lysine: 5g L-lysine in 50ml water, administered orally Normal Saline: Normal (0.9%) Saline
Change in Level of 2-AAA in Urine
7.69 Micromoles
Standard Deviation 4.25

Adverse Events

Participants Administered Oral Lysine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jane Ferguson

VUMC

Phone: 6158759896

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place