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Completed

NCT Number: NCT00625170

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

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.

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Key information

Conditions

Insulin Resistance Dyslipidemia Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Olanzapine

Drug

olanzapine 10 mg/day for 8 days

Other names: Zyprexa

Haloperidol

Drug

haloperidol 3 mg/day for 8 days

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

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Dutch Diabetes Research Foundation

Registry information

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Feb 28, 2008
Registry last updated
Feb 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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