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Molecular Mechanisms of Antipsychotic-induced Insulin Resistance

Primary Purpose

Adverse Effect of Other Antipsychotics and Neuroleptics, Insulin Resistance

Status

Active

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

olanzapine

placebo

About this trial

This is an interventional other trial for Adverse Effect of Other Antipsychotics and Neuroleptics

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

We will include persons that meet the following criteria:

21-45 years old
BMI 18.5-24.9kg/m2
No history of drug or alcohol dependence or abuse
No current or past history of psychiatric or neurologic disease
minimal exercise routine prior or during study (light walking allowed)
Normal liver function tests
minimal alcohol intake (<1 drink per day).

The following persons will be excluded:

Has 1st degree relative with diabetes (I or II)
current or re-cent nicotine intake
presence of organic/physical disease that could affect glucose
currently taking prescription or over-the-counter medications that could affect glucose
currently pregnant or lactating
unwilling to take acceptable birth control method
current or previous exposure to antipsychotics
history of unstable weight
personal or family history of cardiac arrhythmias or seizures
current or past history of eating disorder(s) or restricted diet
allergy to lidocaine or drug excipients
history of difficulty with intravenous line placement
history of fainting.

Sites / Locations

Wayne State University Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

olanzapine

placebo

Arm Description

Atypical antipsychotic

Placebo comparator

Outcomes

Primary Outcome Measures

Change in DNA methylation

Change in peripheral tissue candidate gene methylation will be measured in the olanzapine intervention group compared to placebo

Secondary Outcome Measures

Change in protein levels

Change in peripheral tissue candidate protein levels will be measured in the olanzapine intervention group compared to placebo

Change in protein activity

Change in peripheral tissue candidate protein phosphorylation will be measured in the olanzapine intervention group compared to placebo

Full Information

NCT ID

NCT02708394

First Posted

March 5, 2016

Last Updated

July 11, 2022

Sponsor

Wayne State University

1. Study Identification

Unique Protocol Identification Number

NCT02708394

Brief Title

Molecular Mechanisms of Antipsychotic-induced Insulin Resistance

Official Title

Molecular Mechanisms of Antipsychotic-induced Insulin Resistance in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 1, 2017 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adverse Effect of Other Antipsychotics and Neuroleptics, Insulin Resistance

7. Study Design

Primary Purpose

Other

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

olanzapine

Arm Type

Experimental

Arm Description

Atypical antipsychotic

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Placebo comparator

Intervention Type

Drug

Intervention Name(s)

olanzapine

Other Intervention Name(s)

Zyprexa

Intervention Description

atypical antipsychotic

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo control

Primary Outcome Measure Information:

Title

Change in DNA methylation

Description

Change in peripheral tissue candidate gene methylation will be measured in the olanzapine intervention group compared to placebo

Time Frame

Baseline (day 1) to endpoint of intervention (day 7)

Secondary Outcome Measure Information:

Title

Change in protein levels

Description

Change in peripheral tissue candidate protein levels will be measured in the olanzapine intervention group compared to placebo

Time Frame

Baseline (day 1) to endpoint of intervention (day 7)

Title

Change in protein activity

Description

Change in peripheral tissue candidate protein phosphorylation will be measured in the olanzapine intervention group compared to placebo

Time Frame

Baseline (day 1) to endpoint of intervention (day 7)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Wayne State University Clinical Research Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Molecular Mechanisms of Antipsychotic-induced Insulin Resistance

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