Trial Outcomes & Findings for Inflammation and the Metabolic Syndrome in Humans (NCT NCT00954824)
NCT ID: NCT00954824
Last Updated: 2017-03-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
24 hours
Results posted on
2017-03-30
Participant Flow
Non-tobacco using individuals between ages 18-40 in 2 groups- with metabolic syndrome (having 3 of 5 criteria) and non-metabolic syndrome.
Participant milestones
| Measure |
Endotoxin (LPS)
Single administration low-dose (3 ng/kg) endotoxin (LPS).
Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS).
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inflammation and the Metabolic Syndrome in Humans
Baseline characteristics by cohort
| Measure |
Endotoxin (LPS)
n=50 Participants
Single administration low-dose (3 ng/kg) endotoxin (LPS).
Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS).
|
|---|---|
|
Age, Continuous
|
25.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Endotoxin (LPS)
n=20 Participants
Single administration low-dose (3 ng/kg) endotoxin (LPS).
Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS).
|
|---|---|
|
The Primary Outcome Measure is Plasma Levels of TNF Alpha.
|
507 ng/mL
Standard Deviation 251
|
Adverse Events
Endotoxin (LPS)
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Endotoxin (LPS)
n=100 participants at risk
Single administration low-dose (3 ng/kg) endotoxin (LPS).
Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS).
|
|---|---|
|
Gastrointestinal disorders
Vomitting
|
16.0%
16/100 • Number of events 24
|
|
Musculoskeletal and connective tissue disorders
rigors
|
4.0%
4/100 • Number of events 4
|
|
Cardiac disorders
HR < 50bpm
|
4.0%
4/100 • Number of events 4
|
|
Nervous system disorders
Vagal reaction
|
4.0%
4/100 • Number of events 4
|
|
Vascular disorders
superficial thrombophlebitis
|
4.0%
4/100 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place