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Molecular Mechanisms of Antipsychotic-induced Insulin Resistance

Molecular Mechanisms of Antipsychotic-induced Insulin Resistance in Healthy Volunteers

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02708394
Enrollment
31
Registered
2016-03-15
Start date
2017-02-01
Completion date
2023-10-01
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effect of Other Antipsychotics and Neuroleptics, Insulin Resistance

Brief 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 resistance pathophysiology.

Interventions

DRUGolanzapine

atypical antipsychotic

DRUGplacebo

placebo control

Sponsors

Wayne State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

We will include persons that meet the following criteria: 1. 21-45 years old 2. BMI 18.5-24.9kg/m2 3. No history of drug or alcohol dependence or abuse 4. No current or past history of psychiatric or neurologic disease 5. minimal exercise routine prior or during study (light walking allowed) 6. Normal liver function tests 7. minimal alcohol intake (\<1 drink per day). The following persons will be excluded: 1. Has 1st degree relative with diabetes (I or II) 2. current or re-cent nicotine intake 3. presence of organic/physical disease that could affect glucose 4. currently taking prescription or over-the-counter medications that could affect glucose 5. currently pregnant or lactating 6. unwilling to take acceptable birth control method 7. current or previous exposure to antipsychotics 8. history of unstable weight 9. personal or family history of cardiac arrhythmias or seizures 10. current or past history of eating disorder(s) or restricted diet 11. allergy to lidocaine or drug excipients 12. history of difficulty with intravenous line placement 13. history of fainting.

Design outcomes

Primary

MeasureTime frameDescription
Change in DNA methylationBaseline (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

Secondary

MeasureTime frameDescription
Change in protein levelsBaseline (day 1) to endpoint of intervention (day 7)Change in peripheral tissue candidate protein levels will be measured in the olanzapine intervention group compared to placebo
Change in protein activityBaseline (day 1) to endpoint of intervention (day 7)Change in peripheral tissue candidate protein phosphorylation will be measured in the olanzapine intervention group compared to placebo

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026