Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Antipsychotic Drugs in Healthy Humans

February 19, 2008 updated by: Leiden University Medical Center
We hypothesized that short-term treatment with AP drugs induces insulin resistance through a mechanistic route that is independent of weight gain and that atypical drugs exert stronger effects than typical compounds in this respect. We therefore treated healthy non-obese men with olanzapine (atypical AP) or haloperidol (typical AP) for 8 days, and studied the impact of these interventions on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution technology and indirect calorimetry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

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

  • Netherlands
      • Leiden, Netherlands, 2300 RC
        • Leiden University Medical Center

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy men, with and without a positive family history of schizophrenia.
  • 20 kg/m2 < BMI < 26 kg/m2
  • Age 20-40 years
  • Fasting plasma glucose < 6 mmo/L

Exclusion Criteria:

  • FPG > 6 mmol/L
  • BMI > 26 kg/m2
  • Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past.
  • Any significant chronic disease
  • Renal, hepatic or endocrine disease
  • Use of medication known to influence lipolysis and/or glucose metabolism
  • Total cholesterol > 7mmol/L and/or triglycerides > 2 mmol/L
  • Recent weight changes or attempts to loose weight (> 3 kg weight gain or loss, within the last 3 months)
  • Difficulties to insert an intravenous catheter
  • Smoking (current)
  • Severe claustrophobia (ventilated hood)
  • Recent blood donation (within the last 2 months)
  • Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
  • Extensive sporting activities (more than 10 hours of exercise per week)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Healthy men
Drug: olanzapine
olanzapine 10 mg/day for 8 days
Other Names:
  • Zyprexa
Active Comparator: 2
Healthy men with a positive family anamneses of schizophrenia
Drug: olanzapine
olanzapine 10 mg/day for 8 days
Other Names:
  • Zyprexa
Drug: Haloperidol
haloperidol 3 mg/day for 8 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the effect of subchronic olanzapine and haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation.
Time Frame: 8 days
8 days

Collaborators and Investigators

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

Sponsor

Leiden University Medical Center

Collaborators

Dutch Diabetes Research Foundation

Investigators

  • Study Chair: Hanno Pijl, Phd MD, Leiden University Medical Center

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

May 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Estimate)

February 28, 2008

Last Update Submitted That Met QC Criteria

February 19, 2008

Last Verified

March 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P03.136

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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