Molecular Mechanisms of Antipsychotic-induced Insulin Resistance

NCT ID: NCT02708394

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2023-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adverse Effect of Other Antipsychotics and Neuroleptics Insulin Resistance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

olanzapine

Atypical antipsychotic

Group Type EXPERIMENTAL

olanzapine

Intervention Type DRUG

atypical antipsychotic

placebo

Placebo comparator

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo control

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

olanzapine

atypical antipsychotic

Intervention Type DRUG

placebo

placebo control

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zyprexa

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wayne State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kyle Jon Burghardt, Pharm.D.

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wayne State University Clinical Research Center

Detroit, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MMAAPWSU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dopamine and Insulin in Psychosis
NCT07252752 NOT_YET_RECRUITING NA