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Molecular Mechanisms of Antipsychotic-induced Insulin Resistance

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ClinicalTrials.gov Identifier: NCT02708394
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Kyle Burghardt, 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.

Condition or disease Intervention/treatment Phase
Adverse Effect of Other Antipsychotics and Neuroleptics Insulin Resistance Drug: olanzapine Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 1, 2017
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: olanzapine
Atypical antipsychotic
Drug: olanzapine
atypical antipsychotic
Other Name: Zyprexa

Placebo Comparator: placebo
Placebo comparator
Drug: placebo
placebo control




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in protein levels [ Time Frame: 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 [ Time Frame: 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



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708394


Contacts
Contact: Kyle J Burghardt, Pharm.D. 313-577-3132 kburg@wayne.edu
Contact: Elani Sanders 313-577-1379 pgxresearch@wayne.edu

Locations
United States, Michigan
Wayne State University Clinical Research Center Recruiting
Detroit, Michigan, United States, 48202
Contact: Jackie Parker         
Principal Investigator: Kyle J Burghardt, PharmD         
Sponsors and Collaborators
Wayne State University

Responsible Party: Kyle Burghardt, Assistant Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT02708394     History of Changes
Other Study ID Numbers: MMAAPWSU
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
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
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antipsychotic Agents
Olanzapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents