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NCT02708394

Molecular Mechanisms of Antipsychotic-induced Insulin Resistance

Completed EARLY_PHASE1 Last updated 31 October 2023
What this trial tests

EARLY_PHASE1 trial testing olanzapine in Adverse Effect of Other Antipsychotics and Neuroleptics in 31 participants. Completed in 1 October 2023.

Timeline
1 February 2017
Primary endpoint
1 October 2023
1 October 2023

Quick facts

Lead sponsorWayne State University
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeother
Enrollment31
Start date1 February 2017
Primary completion1 October 2023
Estimated completion1 October 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Wayne State University

Who can join

Adults 21 to 45, any sex, with Adverse Effect of Other Antipsychotics and Neuroleptics or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Alterations in Skeletal Muscle Insulin Signaling DNA Methylation: A Pilot Randomized Controlled Trial of Olanzapine in Healthy Volunteers.
    Burghardt KJ, Burghardt PR, Howlett BH, Dass SE, et al · · 2024 · cited 3× · PMID 38791018 · DOI 10.3390/biomedicines12051057

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Other trials of olanzapine

Trials testing the same drug.

Other Wayne State University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02708394.

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