DiabetesPhase 4NCT01411930
Acute Impact of Intramuscular (IM) Aripiprazole and Olanzapine on Insulin Resistance in High Risk Prediabetics
A Phase 4 study testing Intramuscular olanzapine, aripiprazole and Intramuscular aripiprazole, olanzapine in people with Diabetes, run by Veterans Medical Research Foundation at 1 site in United States.
Trial summary
Antipsychotic medicines used to treat mental illnesses have been associated with effects on blood sugar control. Laboratory studies have shown that certain medications in particular may alter how insulin works. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Intramuscular olanzapine, aripiprazole and Intramuscular aripiprazole, olanzapine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No history of axis I mood, anxiety or psychotic disorder (confirmed by Structured Clinical Interview for DSM-IV), and taking no psychotropics
- Prediabetic, based on a finding of impaired glucose tolerance (2 hour post-load serum glucose 140-199 mg/dl) on a 75 gram standard oral glucose tolerance test within the past 90 days
- Family history of type 2 diabetes mellitus
- BMI 25-35 kg/m2
- Males, ages 40-65 inclusive
- English speaker with ability to provide informed consent
- Nonsmoker
Who cannot join
- History of Axis I Mood, Anxiety or Psychotic Disorder or Use of Psychotropics
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: Acute Impact of IM Aripiprazole and Olanzapine on Insulin Resistance in High Risk Prediabetics
Antipsychotic medicines used to treat mental illnesses have been associated with effects on blood sugar control. Laboratory studies have shown that certain medications in particular may alter how insulin works. One purpose of this study is determine if antipsychotic medications have immediate effects on insulin action in individuals who do not have a mental disorder, but who have risk factors for diabetes. A second purpose is to demonstrate the feasibility of using volunteers without psychiatric disorders, and who do not take psychiatric medications, as a means for studying antipsychotic metabolic effects.
Read the detailed description
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.
- Conditions
- Diabetes
- Being tested
- Intramuscular olanzapine, aripiprazole, Intramuscular aripiprazole, olanzapine
- Keywords
- Insulin resistance, Antipsychotics, Olanzapine, Aripiprazole
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular olanzapine, aripiprazoleDrug
Also called Olanzapine -> Aripiprazole
- 1st clamp: single intramuscular 10.0 mg dose of olanzapine
- 2nd clamp: single intramuscular 9.75 mg dose of aripiprazole
Intramuscular aripiprazole, olanzapineDrug
Also called Aripiprazole -> Olanzapine
- 1st clamp: single intramuscular 9.75 mg dose of aripiprazole
- 2nd clamp: single intramuscular 10.0 mg dose of olanzapine
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine -> Aripiprazole | Experimental | 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). Receives: Drug: Intramuscular olanzapine, aripiprazole |
| Aripiprazole -> Olanzapine | Experimental | 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). Receives: Drug: Intramuscular aripiprazole, olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
2 overnight procedures 4 weeks apart, plus screening procedure
Measured: 6 weeks
Secondary outcomes (1)
Hepatic glucose production
2 overnight procedures 4 weeks apart, plus screening procedure
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Jonathan M. Meyer, MD, Veterans Medical Research Foundation
- Investigators
- Jonathan M Meyer, MD, Principal investigator, VA San Diego and VMRF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411930
- Sponsor's protocol ID
- 080225
- Status last verified
- Dec 2012
- First submitted
- 15 Sep 2009
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Impact of IM Aripiprazole and Olanzapine on Insulin Resistance in High Risk Prediabetics
- ClinicalTrials.gov ID
- NCT01411930
- Acronym / sponsor ID
- 080225
- Conditions
- Diabetes
- Keywords
- Insulin resistance, Antipsychotics, Olanzapine, Aripiprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antipsychotic medicines used to treat mental illnesses have been associated with effects on blood sugar control. Laboratory studies have shown that certain medications in particular may alter how insulin works. One purpose of this study is determine if antipsychotic medications have immediate effects on insulin action in individuals who do not have a mental disorder, but who have risk factors for diabetes. A second purpose is to demonstrate the feasibility of using volunteers without psychiatric disorders, and who do not take psychiatric medications, as a means for studying antipsychotic metabolic effects.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine -> Aripiprazole | Experimental | Drug: Intramuscular olanzapine, aripiprazoleCrossover design. Order of agents is randomized. For this arm, the order will be IM olanzapine (1st clamp study) and IM aripiprazole (2nd clamp study). |
| Aripiprazole -> Olanzapine | Experimental | Drug: Intramuscular aripiprazole, olanzapineCrossover design. Order of agents is randomized. For this arm, the order will be IM aripiprazole (1st clamp study) and IM olanzapine (2nd clamp study). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- No history of axis I mood, anxiety or psychotic disorder (confirmed by Structured Clinical Interview for DSM-IV), and taking no psychotropics
- Prediabetic, based on a finding of impaired glucose tolerance (2 hour post-load serum glucose 140-199 mg/dl) on a 75 gram standard oral glucose tolerance test within the past 90 days
- Family history of type 2 diabetes mellitus
- BMI 25-35 kg/m2
- Males, ages 40-65 inclusive
Key exclusion criteria (1 listed)
- History of Axis I Mood, Anxiety or Psychotic Disorder or Use of Psychotropics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramuscular olanzapine, aripiprazoleAlso: Olanzapine -> Aripiprazole1. 1st clamp: single intramuscular 10.0 mg dose of olanzapine 2. 2nd clamp: single intramuscular 9.75 mg dose of aripiprazole | Drug | Olanzapine -> Aripiprazole |
| Intramuscular aripiprazole, olanzapineAlso: Aripiprazole -> Olanzapine1. 1st clamp: single intramuscular 9.75 mg dose of aripiprazole 2. 2nd clamp: single intramuscular 10.0 mg dose of olanzapine | Drug | Aripiprazole -> Olanzapine |
Primary outcome
Insulin sensitivity
Time frame: 6 weeks
2 overnight procedures 4 weeks apart, plus screening procedure
1 secondary outcome
Hepatic glucose production
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan M Meyer, MD principal investigator
VA San Diego and VMRF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intramuscular olanzapine, aripiprazole and Intramuscular aripiprazole, olanzapine in people with Diabetes, run by Veterans Medical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.