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CompletedNCT00625170Updated Feb 28, 2008

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

An interventional study of olanzapine and Haloperidol in Insulin Resistance and Dyslipidemia, sponsored by Leiden University Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-02-28.

Sponsored by Leiden University Medical Center · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Insulin Resistance
  • Dyslipidemia

Keywords

  • Antipsychotics
  • Olanzapine
  • Haloperidol
  • Insulin resistance
  • Dyslipidemia
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 11 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
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

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)
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
11 participants (actual)

Study arms

  • Active comparator
    1

    Healthy men

    Drug: olanzapine

  • Active comparator
    2

    Healthy men with a positive family anamneses of schizophrenia

    Drug: olanzapine · Drug: Haloperidol

Interventions

  • Drugolanzapine

    olanzapine 10 mg/day for 8 days

    Also known as: Zyprexa

  • DrugHaloperidol

    haloperidol 3 mg/day for 8 days

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • Leiden University Medical Center
    Leiden, 2300 RC, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00625170
Lead sponsor
Leiden University Medical Center
Collaborators
Dutch Diabetes Research Foundation
First posted
Feb 28, 2008
Start date
May 2004
Primary completion
Dec 2004
Completion
Dec 2004
Last update
Feb 28, 2008

Study contacts

Hanno Pijl, Phd MD
study chair · Leiden University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2004. You cannot join it, but the record below documents what was studied.

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