NCT01411930

Brief Summary

Antipsychotic medicines used to treat mental illnesses have been associated with effects on blood sugar control. Laboratory studies have shown that certain medications in particular may alter how insulin works. One purpose of this study is determine if antipsychotic medications have immediate effects on insulin action in individuals who do not have a mental disorder, but who have risk factors for diabetes. A second purpose is to demonstrate the feasibility of using volunteers without psychiatric disorders, and who do not take psychiatric medications, as a means for studying antipsychotic metabolic effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Mar 2009

Typical duration for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

September 15, 2009

Last Update Submit

December 19, 2012

Conditions

Diabetes

Keywords

Insulin resistanceAntipsychoticsOlanzapineAripiprazole

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    2 overnight procedures 4 weeks apart, plus screening procedure

    6 weeks

Secondary Outcomes (1)

  • Hepatic glucose production

    6 weeks

Study Arms (2)

Olanzapine -> Aripiprazole

EXPERIMENTAL

Crossover design. Order of agents is randomized. For this arm, the order will be IM olanzapine (1st clamp study) and IM aripiprazole (2nd clamp study).

Drug: Intramuscular olanzapine, aripiprazole

Aripiprazole -> Olanzapine

EXPERIMENTAL

Crossover design. Order of agents is randomized. For this arm, the order will be IM aripiprazole (1st clamp study) and IM olanzapine (2nd clamp study).

Drug: Intramuscular aripiprazole, olanzapine

Interventions

Intramuscular olanzapine, aripiprazoleDRUG

1. 1st clamp: single intramuscular 10.0 mg dose of olanzapine 2. 2nd clamp: single intramuscular 9.75 mg dose of aripiprazole

Also known as: Olanzapine -> Aripiprazole
Olanzapine -> Aripiprazole
Intramuscular aripiprazole, olanzapineDRUG

1. 1st clamp: single intramuscular 9.75 mg dose of aripiprazole 2. 2nd clamp: single intramuscular 10.0 mg dose of olanzapine

Also known as: Aripiprazole -> Olanzapine
Aripiprazole -> Olanzapine

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No history of axis I mood, anxiety or psychotic disorder (confirmed by Structured Clinical Interview for DSM-IV), and taking no psychotropics
  • Prediabetic, based on a finding of impaired glucose tolerance (2 hour post-load serum glucose 140-199 mg/dl) on a 75 gram standard oral glucose tolerance test within the past 90 days
  • Family history of type 2 diabetes mellitus
  • BMI 25-35 kg/m2
  • Males, ages 40-65 inclusive
  • English speaker with ability to provide informed consent
  • Nonsmoker

You may not qualify if:

  • History of Axis I Mood, Anxiety or Psychotic Disorder or Use of Psychotropics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Interventions

AripiprazoleOlanzapine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzodiazepinesBenzazepines

Study Officials

  • Jonathan M Meyer, MD

    VA San Diego and VMRF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

September 15, 2009

First Posted

August 8, 2011

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

August 1, 2011

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

US(1)