Trial Outcomes & Findings for The Genetics of Evoked Responses to Niacin and Endotoxemia: The GENE Study (NCT NCT00953667)
NCT ID: NCT00953667
Last Updated: 2016-03-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
400 participants
Primary outcome timeframe
Baseline (-15 min, -5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPS
Results posted on
2016-03-24
Participant Flow
400 subjects were enrolled over an approximate 3.5 year period in order to reach target of about 300 subjects completing all visits. Study ended with 277 subjects completing all visits.
All subjects received niacin and LPS doses. There were no separate arms.
Participant milestones
| Measure |
Niacin and Endotoxin
Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
|
|---|---|
|
Overall Study
STARTED
|
400
|
|
Overall Study
COMPLETED
|
277
|
|
Overall Study
NOT COMPLETED
|
123
|
Reasons for withdrawal
| Measure |
Niacin and Endotoxin
Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
|
|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Physician Decision
|
35
|
|
Overall Study
Withdrawal by Subject
|
63
|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
poor venous access,unable to draw blood
|
4
|
Baseline Characteristics
The Genetics of Evoked Responses to Niacin and Endotoxemia: The GENE Study
Baseline characteristics by cohort
| Measure |
Niacin and Endotoxin
n=400 Participants
Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
|
|---|---|
|
Age, Continuous
|
25.42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
198 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
143 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
255 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (-15 min, -5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPSPopulation: This analysis population was categorized by race and gender as follows: European American (EA) male n=102, African American (AA) male n=41, EU female n=91, and AA female n=60. Results include measurements at baseline and peak levels of Tumor Necrosis Factor- alpha (TNF-alpha).
Outcome measures
| Measure |
Niacin/Endotoxin
n=294 Participants
Niacin/Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
|
|---|---|
|
Baseline and Peak TNF-alpha Values as Categorized by Race and Gender
Baseline TNF-alpha in EA males (n=102)
|
1.08 pg/ml
Interval 0.9 to 1.51
|
|
Baseline and Peak TNF-alpha Values as Categorized by Race and Gender
Peak TNF-alpha in EA males (n=102)
|
43.48 pg/ml
Interval 23.38 to 67.08
|
|
Baseline and Peak TNF-alpha Values as Categorized by Race and Gender
Baseline TNF-alpha in AA males (n=41)
|
1.03 pg/ml
Interval 0.73 to 1.37
|
|
Baseline and Peak TNF-alpha Values as Categorized by Race and Gender
Peak TNF-alpha in AA males (n=41)
|
37.28 pg/ml
Interval 17.78 to 51.64
|
|
Baseline and Peak TNF-alpha Values as Categorized by Race and Gender
Baseline TNF-alpha in EA females (n=91)
|
1.06 pg/ml
Interval 0.82 to 1.45
|
|
Baseline and Peak TNF-alpha Values as Categorized by Race and Gender
Peak TNF-alpha in EA females (n=91)
|
43.23 pg/ml
Interval 17.32 to 83.2
|
|
Baseline and Peak TNF-alpha Values as Categorized by Race and Gender
Baseline TNF-alpha in AA females (n=60)
|
1.13 pg/ml
Interval 0.8 to 1.71
|
|
Baseline and Peak TNF-alpha Values as Categorized by Race and Gender
Peak TNF-alpha in AA females (n=60)
|
34.01 pg/ml
Interval 19.1 to 58.06
|
SECONDARY outcome
Timeframe: Baseline ( -15 min, -5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPSPopulation: This analysis population was categorized by race and gender as follows: European American (EA) male n=102, African American (AA) male n=41, EU female n=91, and AA female n=60. Results include measurements at baseline and peak levels of C-Reactive Protein (CRP).
Outcome measures
| Measure |
Niacin/Endotoxin
n=294 Participants
Niacin/Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
|
|---|---|
|
Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender
Baseline CRP in EA females
|
0.62 mg/L
Interval 0.33 to 1.73
|
|
Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender
Baseline CRP in EA males
|
0.34 mg/L
Interval 0.17 to 0.8
|
|
Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender
Peak CRP in EA males
|
17.8 mg/L
Interval 11.23 to 24.23
|
|
Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender
Baseline CRP in AA males
|
0.54 mg/L
Interval 0.34 to 1.19
|
|
Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender
Peak CRP in AA males
|
14.25 mg/L
Interval 9.97 to 21.05
|
|
Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender
Peak CRP in EA females
|
15.9 mg/L
Interval 9.88 to 21.9
|
|
Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender
Baseline CRP in AA females
|
0.71 mg/L
Interval 0.21 to 1.92
|
|
Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender
Peak CRP in AA females
|
10.8 mg/L
Interval 8.18 to 16.1
|
Adverse Events
Niacin and Endotoxin
Serious events: 0 serious events
Other events: 86 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Niacin and Endotoxin
n=400 participants at risk
Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
|
|---|---|
|
Nervous system disorders
Headache
|
3.2%
13/400 • Number of events 13 • AE data collected for approximately 3.5 years, during the course of all study visits
|
|
Gastrointestinal disorders
Vomitting
|
7.0%
28/400 • Number of events 28 • AE data collected for approximately 3.5 years, during the course of all study visits
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
12/400 • Number of events 12 • AE data collected for approximately 3.5 years, during the course of all study visits
|
|
Blood and lymphatic system disorders
>2g drop in Hgb or <10 g/dL
|
4.5%
18/400 • Number of events 18 • AE data collected for approximately 3.5 years, during the course of all study visits
|
|
Cardiac disorders
Lightheadedness
|
3.8%
15/400 • Number of events 15 • AE data collected for approximately 3.5 years, during the course of all study visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place