Adverse Effect of Other Antipsychotics and NeurolepticsEarly Phase 1NCT02708394
Molecular Mechanisms of Antipsychotic-induced Insulin Resistance
A Early Phase 1 study testing olanzapine in people with Adverse Effect of Other Antipsychotics and Neuroleptics and Insulin Resistance, run by Wayne State University at 1 site in United States.
Trial summary
This study will investigate the molecular mechanisms of atypical-antipsychotic induced insulin resistance. This will be accomplished by administering olanzapine or placebo to healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues known to play an important role in insulin… Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Effect of Other Antipsychotics and Neuroleptics, Insulin Resistance
- What is being tested?
- olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 1 Oct 2023
- Phase
- Early Phase 1
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
We will include persons that meet the following criteria:
- 21-45 years old
- BMI 18.5-24.9kg/m2
- No history of drug or alcohol dependence or abuse
- No current or past history of psychiatric or neurologic disease
- minimal exercise routine prior or during study (light walking allowed)
- Normal liver function tests
- minimal alcohol intake (<1 drink per day).
The following persons will be excluded:
- Has 1st degree relative with diabetes (I or II)
- current or re-cent nicotine intake
- presence of organic/physical disease that could affect glucose
- currently taking prescription or over-the-counter medications that could affect glucose
- currently pregnant or lactating
- unwilling to take acceptable birth control method
- current or previous exposure to antipsychotics
- history of unstable weight
- personal or family history of cardiac arrhythmias or seizures
- current or past history of eating disorder(s) or restricted diet
- allergy to lidocaine or drug excipients
- history of difficulty with intravenous line placement
- history of fainting.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University Clinical Research Center
Detroit, Michigan, 48202
About this study
Official title: Molecular Mechanisms of Antipsychotic-induced Insulin Resistance in Healthy Volunteers
This study will investigate the molecular mechanisms of atypical-antipsychotic induced insulin resistance. This will be accomplished by administering olanzapine or placebo to healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues known to play an important role in insulin resistance pathophysiology.
- Being tested
- olanzapine, placebo
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
Also called Zyprexa
atypical antipsychotic
placeboDrug
placebo control
| Study group | Role | What they receive |
|---|---|---|
| olanzapine | Experimental | Atypical antipsychotic Receives: Drug: olanzapine |
| placebo | Placebo comparator | Placebo comparator Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DNA methylation
Change in peripheral tissue candidate gene methylation will be measured in the olanzapine intervention group compared to placebo
Measured: Baseline (day 1) to endpoint of intervention (day 7)
Secondary outcomes (2)
Change in protein levels
Change in peripheral tissue candidate protein levels will be measured in the olanzapine intervention group compared to placebo
Measured: Baseline (day 1) to endpoint of intervention (day 7)
Change in protein activity
Change in peripheral tissue candidate protein phosphorylation will be measured in the olanzapine intervention group compared to placebo
Measured: Baseline (day 1) to endpoint of intervention (day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start1 Feb 2017
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effect of Other Antipsychotics and NeurolepticsStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Jon Burghardt, Pharm.D., Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708394
- Sponsor's protocol ID
- MMAAPWSU
- Status last verified
- Oct 2023
- First submitted
- 5 Mar 2016
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms of Antipsychotic-induced Insulin Resistance in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02708394
- Acronym / sponsor ID
- MMAAPWSU
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 15 Mar 2016 (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.
This study will investigate the molecular mechanisms of atypical-antipsychotic induced insulin resistance. This will be accomplished by administering olanzapine or placebo to healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues known to play an important role in insulin resistance pathophysiology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olanzapine | Experimental | Drug: olanzapineAtypical antipsychotic |
| placebo | Placebo comparator | Drug: placeboPlacebo comparator |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| olanzapineAlso: Zyprexaatypical antipsychotic | Drug | olanzapine |
| placeboplacebo control | Drug | placebo |
Primary outcome
Change in DNA methylation
Time frame: Baseline (day 1) to endpoint of intervention (day 7)
Change in peripheral tissue candidate gene methylation will be measured in the olanzapine intervention group compared to placebo
2 secondary outcomes
Change in protein levels
Time frame: Baseline (day 1) to endpoint of intervention (day 7)
Change in protein activity
Time frame: Baseline (day 1) to endpoint of intervention (day 7)
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 31 Oct 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing olanzapine in people with Adverse Effect of Other Antipsychotics and Neuroleptics and Insulin Resistance, run by Wayne State University 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?
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 31 Oct 2023. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in DNA methylation (time frame: Baseline (day 1) to endpoint of intervention (day 7)). 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 31 Oct 2023.