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Molecular Mechanisms of Antipsychotic-induced Insulin Resistance

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Wayne State University

Status and phase

Completed
Early Phase 1

Conditions

Insulin Resistance
Adverse Effect of Other Antipsychotics and Neuroleptics

Treatments

Drug: olanzapine
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02708394
MMAAPWSU

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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
  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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

31 participants in 2 patient groups, including a placebo group

olanzapine
Experimental group
Description:
Atypical antipsychotic
Treatment:
Drug: olanzapine
placebo
Placebo Comparator group
Description:
Placebo comparator
Treatment:
Drug: placebo

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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