Trial Outcomes & Findings for Racial Differences in Vagal Control of Glucose Homeostasis (NCT NCT02365285)
NCT ID: NCT02365285
Last Updated: 2019-03-19
Results Overview
Measure F-2 isoprostanes as a marker of oxidation
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Baseline to 2 hours
Results posted on
2019-03-19
Participant Flow
52 participants were screen failures and did not receive an intervention.
Participant milestones
| Measure |
Galantamine 16 mg Then Placebo (African-American)
Galantamine 16 mg po one time dose then placebo on 2nd visit
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Galantamine 16 mg Then Placebo (White)
Galantamine 16 mg po one time dose then placebo on 2nd visit
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Placebo Then Galantamine 16 mg (African-American)
Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Placebo Then Galantamine 16 mg (White)
Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
7
|
3
|
|
Overall Study
COMPLETED
|
7
|
5
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Galantamine 16 mg Then Placebo (African-American)
Galantamine 16 mg po one time dose then placebo on 2nd visit
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Galantamine 16 mg Then Placebo (White)
Galantamine 16 mg po one time dose then placebo on 2nd visit
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Placebo Then Galantamine 16 mg (African-American)
Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Placebo Then Galantamine 16 mg (White)
Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Racial Differences in Vagal Control of Glucose Homeostasis
Baseline characteristics by cohort
| Measure |
Galantamine 16 mg Then Placebo (African-American)
n=7 Participants
Galantamine 16 mg po one time dose then placebo on 2nd visit
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Galantamine 16 mg Then Placebo (White)
n=6 Participants
Galantamine 16 mg po one time dose then placebo on 2nd visit
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Placebo Then Galantamine 16 mg (African-American)
n=7 Participants
Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Placebo Then Galantamine 16 mg (White)
n=3 Participants
Placebo capsule po one time dose then Galantamine 16 mg on 2nd visit
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
3 participants
n=4 Participants
|
23 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 hoursPopulation: 2 white participants dropped out due to nausea. 1 African-American was withdrawn, MD decision.
Measure F-2 isoprostanes as a marker of oxidation
Outcome measures
| Measure |
Galantamine 16 mg (African-American)
n=13 Participants
Galantamine 16 mg po one time dose
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Galantamine 16 mg (White)
n=7 Participants
Galantamine 16 mg po one time dose
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Placebo (African-American)
n=13 Participants
Placebo capsule po one time dose
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Placebo (White)
n=7 Participants
Placebo capsule po one time dose
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
|---|---|---|---|---|
|
Change in Oxidative Stress: Baseline to 2 Hours
|
-0.003 pg /ml
Standard Deviation 0.012
|
-0.006 pg /ml
Standard Deviation 0.018
|
0.01 pg /ml
Standard Deviation 0.018
|
-0.006 pg /ml
Standard Deviation 0.01
|
PRIMARY outcome
Timeframe: Baseline to 4 hoursPopulation: 1 white participant did not have 4 hour F-2 isoprostanes drawn after receiving placebo. 2 white participants dropped out due to nausea. 1 African-American was withdrawn, MD decision.
Measure F-2 isoprostanes as a marker of oxidation
Outcome measures
| Measure |
Galantamine 16 mg (African-American)
n=13 Participants
Galantamine 16 mg po one time dose
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Galantamine 16 mg (White)
n=7 Participants
Galantamine 16 mg po one time dose
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Placebo (African-American)
n=13 Participants
Placebo capsule po one time dose
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Placebo (White)
n=6 Participants
Placebo capsule po one time dose
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
|---|---|---|---|---|
|
Change in Oxidative Stress: Baseline to 4 Hours
|
0 pg/ml
Standard Deviation 0.016
|
-0.008 pg/ml
Standard Deviation 0.014
|
0.003 pg/ml
Standard Deviation 0.005
|
-0.008 pg/ml
Standard Deviation 0.014
|
Adverse Events
Galantamine 16 mg (African-American)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Galantamine 16 mg (White)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo (African-American)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (White)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Galantamine 16 mg (African-American)
n=14 participants at risk
Galantamine 16 mg po one time dose
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Galantamine 16 mg (White)
n=9 participants at risk
Galantamine 16 mg po one time dose
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Placebo (African-American)
n=14 participants at risk
Placebo capsule po one time dose
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
Placebo (White)
n=9 participants at risk
Placebo capsule po one time dose
Intralipid: Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
Heparin: heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea and Vomiting
|
21.4%
3/14 • Number of events 3 • Baseline through 2nd study day, usually about 1 month.
|
55.6%
5/9 • Number of events 5 • Baseline through 2nd study day, usually about 1 month.
|
14.3%
2/14 • Number of events 2 • Baseline through 2nd study day, usually about 1 month.
|
11.1%
1/9 • Number of events 1 • Baseline through 2nd study day, usually about 1 month.
|
|
General disorders
Lightheadness
|
0.00%
0/14 • Baseline through 2nd study day, usually about 1 month.
|
0.00%
0/9 • Baseline through 2nd study day, usually about 1 month.
|
7.1%
1/14 • Number of events 1 • Baseline through 2nd study day, usually about 1 month.
|
11.1%
1/9 • Number of events 1 • Baseline through 2nd study day, usually about 1 month.
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.1%
1/14 • Number of events 1 • Baseline through 2nd study day, usually about 1 month.
|
0.00%
0/9 • Baseline through 2nd study day, usually about 1 month.
|
0.00%
0/14 • Baseline through 2nd study day, usually about 1 month.
|
0.00%
0/9 • Baseline through 2nd study day, usually about 1 month.
|
|
General disorders
Headache
|
0.00%
0/14 • Baseline through 2nd study day, usually about 1 month.
|
11.1%
1/9 • Number of events 1 • Baseline through 2nd study day, usually about 1 month.
|
0.00%
0/14 • Baseline through 2nd study day, usually about 1 month.
|
0.00%
0/9 • Baseline through 2nd study day, usually about 1 month.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place