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Molecular Mechanisms of Antipsychotic-induced Insulin Resistance

Sponsor
Wayne State University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02708394
Collaborator
(none)
76
Enrollment
1
Location
2
Arms
88.9
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Molecular Mechanisms of Antipsychotic-induced Insulin Resistance in Healthy Volunteers
Actual Study Start Date :
Feb 1, 2017
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: olanzapine

Atypical antipsychotic

Drug: olanzapine
atypical antipsychotic
Other Names:
  • Zyprexa

    		•
    Placebo Comparator: placebo

    Placebo comparator

    Drug: placebo
    placebo control

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wayne State University Clinical Research Center Detroit Michigan United States 48202

    Sponsors and Collaborators

    • Wayne State University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyle Jon Burghardt, Pharm.D., Assistant Professor, Wayne State University
    ClinicalTrials.gov Identifier:
    NCT02708394
    Other Study ID Numbers:
    • MMAAPWSU
    First Posted:
    Mar 15, 2016
    Last Update Posted:
    Jul 12, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Insulin Resistance
    Olanzapine

    Study Results

    No Results Posted as of Jul 12, 2022