Molecular Mechanisms of Antipsychotic-induced Insulin Resistance

Early Phase 1

Completed

• Conditions: Adverse Effect of Other Antipsychotics and Neuroleptics; Insulin Resistance
• Interventions: Drug: placebo; Drug: olanzapine

• Registration Number: NCT02708394
• Lead Sponsor: Wayne State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-05
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Study Start: 2017-02-01
• Status Verified: 2023-10
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Placebo comparator
olanzapine	olanzapine	Atypical antipsychotic

Primary Outcome Measures

Name	Time	Method
Change in DNA methylation	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

Secondary Outcome Measures

Name	Time	Method
Change in protein activity	Baseline (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
Change in protein levels	Baseline (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

Trial Locations

Locations (1)

Wayne State University Clinical Research Center; 🇺🇸 Detroit, Michigan, United States