Acute Impact of Intramuscular (IM) Aripiprazole and Olanzapine on Insulin Resistance in High Risk Prediabetics
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|ClinicalTrials.gov Identifier: NCT01411930|
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : December 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Drug: Intramuscular olanzapine, aripiprazole Drug: Intramuscular aripiprazole, olanzapine||Phase 4|
Antipsychotic medications are those that treat the most severe psychiatric symptoms, such as hallucinations, paranoid thoughts, and delusions. Research shows that some of these medications may put people at a higher risk of metabolic derangements, such as insulin resistance. Certain antipsychotics, like clozapine and olanzapine, are associated with a higher risk of metabolic side effects than others, like aripiprazole and ziprasidone. This study will compare the effects of single doses of two antipsychotic medications, olanzapine and aripiprazole, on insulin action in nonpsychiatrically ill volunteer subjects.
Participation in this study will last 6 weeks. Participants will first complete a screening visit that will include the following: an oral glucose tolerance test (OGTT), which involves a blood draw, consumption of a sugar drink, and then a second blood draw; a review of medical and psychiatric history, including use of medicines and psychiatric medications; and measurement of participants' height and weight. The second visit, scheduled 2 weeks after screening, will include a tracer-clamp study to test how participants' bodies handle sugar. The tracer-clamp study will be conducted over the course of one night and morning and will require participants to stay at the study location overnight. At 3 AM, participants will receive an intravenous line (IV) with a sugar solution. Just before 8 AM, they will receive a second IV in the opposite arm that will draw blood and monitor blood sugar levels.
At 8 AM, participants will begin receiving insulin in the first IV; blood samples will be drawn and blood sugar levels will be monitored during this time to ensure they remain within a healthy range. At 11 AM, participants will receive an injection of an antipsychotic medication into their arm muscles. The antipsychotic, which will be randomly assigned, will be either olanzapine or aripiprazole. Participants will be monitored for 3 hours after receiving the injection of antipsychotic medication; during this time, more blood samples will be drawn, blood sugar levels will be monitored to ensure they are within a healthy range, and secondary medications will be available to counteract certain side effects of the antipsychotics.
After 4 more weeks, participants will undergo a 2nd tracer-clamp study, this time receiving the antipsychotic not given in the first clamp study. The protocol for this visit is otherwise identical to the first clamp study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Acute Impact of IM Aripiprazole and Olanzapine on Insulin Resistance in High Risk Prediabetics|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||August 2011|
Experimental: Olanzapine -> Aripiprazole
Crossover design. Order of agents is randomized. For this arm, the order will be IM olanzapine (1st clamp study) and IM aripiprazole (2nd clamp study).
Drug: Intramuscular olanzapine, aripiprazole
Other Name: Olanzapine -> Aripiprazole
Experimental: Aripiprazole -> Olanzapine
Crossover design. Order of agents is randomized. For this arm, the order will be IM aripiprazole (1st clamp study) and IM olanzapine (2nd clamp study).
Drug: Intramuscular aripiprazole, olanzapine
Other Name: Aripiprazole -> Olanzapine
- Insulin sensitivity [ Time Frame: 6 weeks ]2 overnight procedures 4 weeks apart, plus screening procedure
- Hepatic glucose production [ Time Frame: 6 weeks ]2 overnight procedures 4 weeks apart, plus screening procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411930
|United States, California|
|VA San Diego Healthcare System|
|San Diego, California, United States, 92161|
|Principal Investigator:||Jonathan M Meyer, MD||VA San Diego and VMRF|