Examining the Effects of Antipsychotic Medications on Insulin Sensitivity
Acute Impact of Antipsychotics on Insulin Sensitivity: A Novel Human Model
3 other identifiers
interventional
30
1 country
1
Brief Summary
This study will examine the effects of two different antipsychotic medications on control of blood sugar in people who are at risk of diabetes but mentally healthy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 diabetes
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 7, 2009
CompletedFirst Posted
Study publicly available on registry
May 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
August 11, 2020
CompletedAugust 11, 2020
August 1, 2020
1.1 years
May 7, 2009
November 25, 2016
August 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Glucose Disposition
Ratio of post-antipsychotic/pre-antipsychotic glucose disposition as measured using the hyperglycemic clamp technique. This method allows one to measure either how well an individual metabolizes glucose or how sensitive an individual is to insulin.
Measured over 6 hours
Secondary Outcomes (2)
Change in Percent of Insulin Suppression of Endogenous Glucose Production
Measured over 6 hours
Akathisia
6 hours
Study Arms (2)
Aripiprazole
ACTIVE COMPARATORParticipants will receive an injection of aripiprazole during the tracer-clamp study.
Olanzapine
ACTIVE COMPARATORParticipants will receive an injection of olanzapine during the tracer-clamp study.
Interventions
Eligibility Criteria
You may qualify if:
- Prediabetic, defined as 2-hour post-load serum glucose between 140 and 199 mg/dl on a 75-gram standard oral glucose tolerance test (OGTT) within the past 90 days
- Family history of type 2 diabetes mellitus
- Body mass index (BMI) between 25 and 35 kg/m2
- English speaker
- Nonsmoker
You may not qualify if:
- History of Axis I mood, anxiety, or psychotic disorder, confirmed by Structured Clinical Interview for DSM-IV
- Use of psychotropic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System
San Diego, California, 92161, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan M. Meyer, MD
- Organization
- Veterans Medical Research Foundation
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan M. Meyer, MD
UCSD and Veterans Affairs San Diego
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
May 7, 2009
First Posted
May 8, 2009
Study Start
November 1, 2008
Primary Completion
December 1, 2009
Study Completion
June 1, 2010
Last Updated
August 11, 2020
Results First Posted
August 11, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share