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

NCT ID: NCT00625170

Last Updated: 2008-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Insulin Resistance Dyslipidemia

Keywords

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Antipsychotics Olanzapine Haloperidol Insulin resistance Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Healthy men

Group Type ACTIVE_COMPARATOR

olanzapine

Intervention Type DRUG

olanzapine 10 mg/day for 8 days

2

Healthy men with a positive family anamneses of schizophrenia

Group Type ACTIVE_COMPARATOR

olanzapine

Intervention Type DRUG

olanzapine 10 mg/day for 8 days

Haloperidol

Intervention Type DRUG

haloperidol 3 mg/day for 8 days

Interventions

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olanzapine

olanzapine 10 mg/day for 8 days

Intervention Type DRUG

Haloperidol

haloperidol 3 mg/day for 8 days

Intervention Type DRUG

Other Intervention Names

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Zyprexa

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dutch Diabetes Research Foundation

OTHER

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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LUMC

Principal Investigators

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Hanno Pijl, Phd MD

Role: STUDY_CHAIR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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P03.136

Identifier Type: -

Identifier Source: org_study_id