Janssen - Glucose Regulation/Risp/Olanz

March 12, 2014 updated by: Washington University School of Medicine

Glucose Regulation During Risperidone and Olanzapine Treatment

Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in individuals with schizophrenia than in healthy subjects or in other psychiatric conditions. Antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Hyperglycemia can contribute to long-term cardiovascular disease risk that may already be increased in patients with schizophrenia due to higher rates of smoking, sedentary life style, obesity and under-treated hypertension and dyslipidemia. This project will characterize the effects on glucose control of the two most commonly prescribed newer antipsychotic medications, risperidone and olanzapine, in patients with schizophrenia.

This proposal specifically hypothesizes that olanzapine treatment will be associated with decreases in insulin sensitivity (SI), without effects on insulin secretion. Treatment-related effects on glucose effectiveness (SG) will be explored.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This proposal aims to use a well-characterized procedure, the modified Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT), to characterize the glucoregulatory effects of the two most commonly prescribed atypical antipsychotic medications, risperidone and olanzapine, in comparison to the conventional antipsychotic haloperidol. Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in individuals with schizophrenia than in healthy subjects or in other psychiatric conditions. While abnormalities in glucose regulation were first reported in schizophrenia prior to the introduction of antipsychotic medications, antipsychotic treatment may contribute significantly to abnormalities in glucose regulation.

Recently, the adverse effect of antipsychotic medications on systemic glucose regulation has received increased attention as investigators noted prominent adverse glucoregulatory effects associated with certain newer antipsychotic medications. Abnormal glucose regulation and new-onset type 2 diabetes have been reported during clozapine and olanzapine treatment. Complicating the study of antipsychotic-induced changes in glucose regulation, increased adiposity can decrease insulin sensitivity, and antipsychotics can increase adiposity and body mass index (BMI). However, abnormal glucose regulation and type 2 diabetes can occur during clozapine treatment in the absence of weight gain, suggesting that changes in glucose regulation can occur independent of drug-induced increases in BMI. Consistent with this, our preliminary studies indicate that important effects of clozapine and olanzapine on glucose regulation are not accounted for by differences in BMI. This proposal will compare the effects of olanzapine, risperidone and haloperidol on well-defined measures of glucose regulation.

This proposal specifically hypothesizes that olanzapine treatment will be associated with decreases in insulin sensitivity (SI), without effects on insulin secretion. Treatment-related effects on glucose effectiveness (SG) will be explored.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine, Psychiatry Dept.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients: meets DSM-IV criteria for schizophrenia, any type, or schizoaffective disorder;
  2. Aged 18 to 60 years;
  3. Able to give informed consent;
  4. No medication changes for 2 weeks prior to and during the period of study; 5. Patients: currently taking olanzapine, risperidone, haloperidol or another typical antipsychotic.

Exclusion Criteria:

  1. Controls: Axis I psychiatric disorder criteria met except for substance use disorders as below;
  2. Meets DSM-IV criteria for the diagnoses of substance abuse or dependence within the past six months;
  3. Involuntary legal status (as per Missouri law);
  4. The presence of any serious medical disorder that may (as confirmed by peer-reviewed literature) confound the assessment of symptoms, relevant biologic measures or diagnosis; the following conditions are currently identified: insulin- or non-insulin-dependent diabetes mellitus; any intra-abdominal or intrathoracic surgery or limb amputation within the prior 6 months; any diagnosed cardiac condition causing documented hemodynamic compromise; any diagnosed respiratory condition causing documented or clinically recognized hypoxia; pregnancy or high dose estrogens, fever, narcotic therapy, acute sedative hypnotic withdrawal, corticosteroid or spironolactone therapy, dehydration, epilepsy, endocrine disease, high-dose benzodiazepine therapy (> 25 mg/day of diazepam), or any medical condition known to interfere with glucose utilization;
  5. Meets DSM-IV criteria for Mental Retardation (mild or worse).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effects of olanzapine/risperidone/haloperidol on glucose regulation.

Secondary Outcome Measures

Outcome Measure
Explore Treatment-related effects on glucose effectiveness.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: John W. Newcomer, M.D., Washington University School of Medicine and Florida Atlantic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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