Molecular Mechanisms of Antipsychotic-induced Insulin Resistance

Insulin Resistance Clinical Trial

Official title:

Molecular Mechanisms of Antipsychotic-induced Insulin Resistance in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708394
• Other study ID #: MMAAPWSU
• Status: Completed
• Phase: Early Phase 1
• Start date: February 1, 2017
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Effect of Other Antipsychotics and Neuroleptics
• Insulin Resistance

Intervention

Drug:
• olanzapine
atypical antipsychotic
• placebo
placebo control

Locations

Country	Name	City	State
United States	Wayne State University Clinical Research Center	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in DNA methylation	Change in peripheral tissue candidate gene methylation will be measured in the olanzapine intervention group compared to placebo	Baseline (day 1) to endpoint of intervention (day 7)
Secondary	Change in protein levels	Change in peripheral tissue candidate protein levels will be measured in the olanzapine intervention group compared to placebo	Baseline (day 1) to endpoint of intervention (day 7)
Secondary	Change in protein activity	Change in peripheral tissue candidate protein phosphorylation will be measured in the olanzapine intervention group compared to placebo	Baseline (day 1) to endpoint of intervention (day 7)