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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00625170
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : February 28, 2008
Dutch Diabetes Research Foundation
Information provided by:
Leiden University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Dyslipidemia Drug: olanzapine Drug: Haloperidol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Antipsychotic Drugs in Healthy Humans
Study Start Date : May 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Healthy men
Drug: olanzapine
olanzapine 10 mg/day for 8 days
Other Name: Zyprexa

Active Comparator: 2
Healthy men with a positive family anamneses of schizophrenia
Drug: olanzapine
olanzapine 10 mg/day for 8 days
Other Name: Zyprexa

Drug: Haloperidol
haloperidol 3 mg/day for 8 days

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00625170

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Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Sponsors and Collaborators
Leiden University Medical Center
Dutch Diabetes Research Foundation
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Study Chair: Hanno Pijl, Phd MD Leiden University Medical Center
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Responsible Party: Prof. Hanno Pijl, LUMC Identifier: NCT00625170    
Other Study ID Numbers: P03.136
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: February 28, 2008
Last Verified: March 2004
Keywords provided by Leiden University Medical Center:
Insulin resistance
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Haloperidol decanoate
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Dopamine Antagonists
Dopamine Agents
Anti-Dyskinesia Agents