Trial Outcomes & Findings for Examining the Effects of Antipsychotic Medications on Insulin Sensitivity (NCT NCT00895921)
NCT ID: NCT00895921
Last Updated: 2020-08-11
Results Overview
Ratio of post-antipsychotic/pre-antipsychotic glucose disposition as measured using the hyperglycemic clamp technique. This method allows one to measure either how well an individual metabolizes glucose or how sensitive an individual is to insulin.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Measured over 6 hours
Results posted on
2020-08-11
Participant Flow
Participant milestones
| Measure |
Aripiprazole
Participants will receive an injection of aripiprazole during the trace-clamp study.
Aripiprazole: Single intramuscular 9.75-mg dose
|
Olanzapine
Participants will receive an injection of olanzapine during the trace-clamp study.
Olanzapine: Single intramuscular 10-mg dose
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Examining the Effects of Antipsychotic Medications on Insulin Sensitivity
Baseline characteristics by cohort
| Measure |
Aripiprazole
n=15 Participants
Participants will receive an injection of aripiprazole during the tracer-clamp study.
Aripiprazole: Single intramuscular 9.75-mg dose
|
Olanzapine
n=15 Participants
Participants will receive an injection of olanzapine during the tracer-clamp study.
Olanzapine: Single intramuscular 10-mg dose
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 5.57 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 5.97 • n=7 Participants
|
51.17 years
STANDARD_DEVIATION 5.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Glucose Disposition
|
3.88 mg/kg/min
STANDARD_DEVIATION 1.99 • n=5 Participants
|
3.31 mg/kg/min
STANDARD_DEVIATION 1.35 • n=7 Participants
|
3.60 mg/kg/min
STANDARD_DEVIATION 1.67 • n=5 Participants
|
|
Insulin Suppression of Endogenous Glucose Production (EGP)
|
84.28 % suppression of EGP
STANDARD_DEVIATION 20.30 • n=5 Participants
|
86.52 % suppression of EGP
STANDARD_DEVIATION 22.34 • n=7 Participants
|
85.40 % suppression of EGP
STANDARD_DEVIATION 21.32 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured over 6 hoursRatio of post-antipsychotic/pre-antipsychotic glucose disposition as measured using the hyperglycemic clamp technique. This method allows one to measure either how well an individual metabolizes glucose or how sensitive an individual is to insulin.
Outcome measures
| Measure |
Aripiprazole
n=15 Participants
Participants will receive an injection of aripiprazole during the tracer-clamp study.
Aripiprazole: Single intramuscular 9.75-mg dose
|
Olanzapine
n=15 Participants
Participants will receive an injection of olanzapine during the tracer-clamp study.
Olanzapine: Single intramuscular 10-mg dose
|
|---|---|---|
|
Change in Glucose Disposition
|
1.18 ratio of post/pre values
Standard Deviation .324
|
1.42 ratio of post/pre values
Standard Deviation .300
|
SECONDARY outcome
Timeframe: Measured over 6 hoursRatio of Post-Antipsychotic/Pre-Antipsychotic Percent of Insulin Suppression of Endogenous Glucose Production
Outcome measures
| Measure |
Aripiprazole
n=15 Participants
Participants will receive an injection of aripiprazole during the tracer-clamp study.
Aripiprazole: Single intramuscular 9.75-mg dose
|
Olanzapine
n=15 Participants
Participants will receive an injection of olanzapine during the tracer-clamp study.
Olanzapine: Single intramuscular 10-mg dose
|
|---|---|---|
|
Change in Percent of Insulin Suppression of Endogenous Glucose Production
|
1.0594 ratio of post/pre values
Standard Deviation .519
|
1.312 ratio of post/pre values
Standard Deviation .642
|
SECONDARY outcome
Timeframe: 6 hoursNumber of subjects reporting mild or greater complaints of akathisia after antipsychotic administration
Outcome measures
| Measure |
Aripiprazole
n=15 Participants
Participants will receive an injection of aripiprazole during the tracer-clamp study.
Aripiprazole: Single intramuscular 9.75-mg dose
|
Olanzapine
n=15 Participants
Participants will receive an injection of olanzapine during the tracer-clamp study.
Olanzapine: Single intramuscular 10-mg dose
|
|---|---|---|
|
Akathisia
|
1 participants
|
7 participants
|
Adverse Events
Aripiprazole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Olanzapine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aripiprazole
n=15 participants at risk
Participants will receive an injection of aripiprazole during the tracer-clamp study.
Aripiprazole: Single intramuscular 9.75-mg dose
|
Olanzapine
n=15 participants at risk
Participants will receive an injection of olanzapine during the tracer-clamp study.
Olanzapine: Single intramuscular 10-mg dose
|
|---|---|---|
|
Psychiatric disorders
Akathisia
|
6.7%
1/15 • Number of events 1 • 1 day
|
46.7%
7/15 • Number of events 7 • 1 day
|
Additional Information
Jonathan M. Meyer, MD
Veterans Medical Research Foundation
Phone: 858-964-0777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place