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Completed

NCT Number: NCT02708394

Molecular Mechanisms of Antipsychotic-induced Insulin Resistance

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.

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Key information

Conditions

Adverse Effect of Other Antipsychotics and Neuroleptics Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Wayne State University Clinical Research Center

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olanzapine

Drug

atypical antipsychotic

Other names: Zyprexa

Placebo

Drug

placebo control

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

Molecular Mechanisms of Antipsychotic-induced Insulin Resistance in Healthy Volunteers

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2016
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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