Examining the Effects of Antipsychotic Medications on Insulin Sensitivity

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonathan M. Meyer, MD, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00895921
First received: May 7, 2009
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Diabetes
Drug: Olanzapine
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Acute Impact of Antipsychotics on Insulin Sensitivity: A Novel Human Model

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Measured over 6 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hepatic glucose production [ Time Frame: Measured over 6 hours ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will receive an injection of aripiprazole during the trace-clamp study.
Drug: Aripiprazole
Single intramuscular 9.75-mg dose
Other Name: Abilify
Active Comparator: 2
Participants will receive an injection of olanzapine during the trace-clamp study.
Drug: Olanzapine
Single intramuscular 10-mg dose
Other Name: Zyprexa

Detailed Description:

Antipsychotic medications are those that treat the most severe psychiatric symptoms, such as hallucinations, paranoid thoughts, and delusions. Research shows that some of these medications may put people at a higher risk of metabolic derangements, such as insulin resistance. Certain antipsychotics, like clozapine and olanzapine, are associated with a higher risk of metabolic side effects than others, like aripiprazole and ziprasidone. Because people with schizophrenia may experience adverse side effects from switching antipsychotic medications and because it is difficult to find people with schizophrenia who do not have experience taking antipsychotics, this study will use people without psychiatric disorders who are at risk for diabetes in place of people with schizophrenia. The study will compare the effects of single doses of two antipsychotic medications, olanzapine and aripiprazole, on insulin action in this population. In addition to determining metabolic effects of these medications, this study will also seek to demonstrate the feasibility of using mentally healthy people at risk of diabetes as a substitute for people with schizophrenia in studying these effects.

Participation in this study will last 4 weeks. Participants will first complete a screening visit that will include the following: an oral glucose tolerance test (OGTT), which involves a blood draw, consumption of a sugar drink, and then a second blood draw; a review of medical and psychiatric history, including use of medicines and psychiatric medications; and measurement of participants' height and weight. The second visit, scheduled 2 weeks after screening, will include a tracer-clamp study to test how participants' bodies handle sugar. The tracer-clamp study will be conducted over the course of one night and morning and will require participants to stay at the study location overnight. At 3 AM, participants will receive an intravenous line (IV) with a sugar solution. Just before 8 AM, they will receive a second IV in the opposite arm that will draw blood and monitor blood sugar levels.

At 8 AM, participants will begin receiving insulin in the first IV; blood samples will be drawn and blood sugar levels will be monitored during this time to ensure they remain within a healthy range. At 11 AM, participants will receive an injection of an antipsychotic medication into their arm muscles. The antipsychotic, which will be randomly assigned, will be either olanzapine or aripiprazole. Participants will be monitored for 3 hours after receiving the injection of antipsychotic medication; during this time, more blood samples will be drawn, blood sugar levels will be monitored to ensure they are within a healthy range, and secondary medications will be available to counteract certain side effects of the antipsychotics. After 2 more weeks, participants will undergo a third study visit in which they repeat the OGTT.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of Axis I mood, anxiety, or psychotic disorder, confirmed by Structured Clinical Interview for DSM-IV
  • Use of psychotropic drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895921

Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
Investigators
Principal Investigator: Jonathan M. Meyer, MD University of California, San Diego and Veterans Affairs San Diego
  More Information

No publications provided

Responsible Party: Jonathan M. Meyer, MD, Research Scientist, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00895921     History of Changes
Other Study ID Numbers: R21 MH082805, R21MH082805, DATR A5-ETSE
Study First Received: May 7, 2009
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Veterans Medical Research Foundation:
Insulin Resistance
Antipsychotic Medications

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Antipsychotic Agents
Olanzapine
Aripiprazole
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on September 14, 2014