Influence of Treatment With Olanzapine or Ziprasidone on Transcapillary Glucose Transport in Human Skeletal Muscle

October 17, 2006 updated by: Medical University of Vienna
Healthy volunteers will undergo euglycaemic hyperinsulinaemic clamp and microdialysis before and after administration of 10mg olanzapine or 80mg ziprasidone during 10 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

The efficacy of atypical antipsychotics, such as olanzapine, clozapine, risperidone, quetiapine and ziprasidone in treating a broad spectrum of symptoms in schizophrenia as well as their lower likelihood of extrapyramidal symptoms have led to an increased use of these substances. However there is an ongoing debate whether treatment with atypical antipsychotics is associated with a higher risk for metabolic abnormalities. The FDA stated in 2003 that all atypical antipsychotics increase the risk for glucose abnormalities. For olanzapine many, but not all studies report an increased risk for the development of metabolic abnormalities, such as glucose intolerance, insulin-resistance and consequentially NIDDM (Non-Insulin-Dependent-Diabetes Mellitus). Ziprasidone on the other hand seems to be associated with a more favorable metabolic safety profile.Glucose intolerance and insulin resistance being risk factors for the development of NIDDM and cardiovascular disease, the exact determination of putative effects of atypical antipsychotics on insulin sensitivity and resistance is of great need. An innovative technique, microdialysis, allows for the measurement of various analytes in the interstitial space, i.e. to assess insulin sensitivity directly at the responsible compartment, which is the human skeletal muscle. With the use of microdialysis it is possible to determine the arterial to interstitial gradient, a suitable marker for plasma glucose extraction of peripheral tissue, and thus detect insulin resistance directly at the site of insulin action.

Aim of the study:

To compare the effects of treatment with the atypical antipsychotics olanzapine and ziprasidone in steady-state conditions on the arterial to interstitial skeletal muscle gradient for glucose in human skeletal muscle during euglycaemic hyperinsulinaemic clamp conditions in male healthy volunteers.

Study design:

Open, randomized, mono-center study.

Materials and methods:

Healthy volunteers will undergo euglycaemic hyperinsulinaemic clamp and microdialysis before and after administration of 10mg olanzapine or 80mg ziprasidone during 10 days.

Study population:

15 healthy volunteers will participate in each arm of the study, summing up to a total of 30 participants.

Main outcome variable:

The arterial to interstitial skeletal muscle glucose gradient before and during euglycaemic hyperinsulinaemic clamp conditions, before and after administration of 10mg olanzapine or 80mg ziprasidone under steady-state conditions.

Study Type

Interventional

Phase

  • Phase 4

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

  • Austria
      • Vienna, Austria, 1090
        • Department of Clinical Pharmacology, Medical University Vienna

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age between 18-55
  • Healthy male volunteers
  • No history of drug or alcohol abuse
  • No regular nicotine consumption at time of enrollment
  • Physical activity at least twice a week
  • Body mass Index between 19-24 kg/m2
  • Normal laboratory values
  • Normotension (blood pressure less than 140/90)
  • No past or present history of psychiatric disorder
  • No family history of diabetes or obesity
  • Written informed consent

Exclusion Criteria:

  • Use of medication within the last 14 days
  • Consumption of alcohol within the last 5 days
  • Family history of diabetes or obesity
  • Past or present psychiatric disorder

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Siegfried Kasper, Prof. MD, Medical University Vienna, Department of General Psychiatry

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.

General Publications

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

April 1, 2005

Study Registration Dates

First Submitted

February 28, 2006

First Submitted That Met QC Criteria

February 28, 2006

First Posted (Estimate)

March 1, 2006

Study Record Updates

Last Update Posted (Estimate)

October 18, 2006

Last Update Submitted That Met QC Criteria

October 17, 2006

Last Verified

October 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • olanz/zipra
  • EUDRACT Nr.: 2004-002147-27

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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