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

This study has been completed.

First Received: February 19, 2008 No Changes Posted

Sponsors and Collaborators:	Leiden University Medical Center Dutch Diabetes Foundation
Information provided by:	Leiden University Medical Center
ClinicalTrials.gov Identifier:	NCT00625014

Purpose

We hypothesized that short-term treatment with haloperidol induces insulin resistance through a mechanistic route that is independent of weight gain. We therefore treated healthy non-obese men with haloperidol for 8 days, and studied the impact of these intervention on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution technology and indirect calorimetry.

Condition	Intervention
Insulin Resistance Dyslipidemia	Drug: Haloperidol

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment
Official Title:	Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans

Resource links provided by NLM:

Drug Information available for: Dopamine Haloperidol Dopamine hydrochloride Haloperidol decanoate Haloperidol lactate

U.S. FDA Resources

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:

To determine the effect of subchronic haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation. [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Enrollment:	8
Study Start Date:	March 2005
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Healthy men	Drug: Haloperidol Haloperidol 3 mg/day for 8 days

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy men
20 kg/m2 < BMI < 26 kg/m2
Age 20-40 years
FPG < 6 mmol/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.
A positive family history of schizophrenia
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625014

Locations

Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 RC

Sponsors and Collaborators

Leiden University Medical Center

Dutch Diabetes Foundation

More Information

No publications provided

Responsible Party:	Leiden University Medical Center ( Prof H Pijl )
Study ID Numbers:	P05.009
Study First Received:	February 19, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00625014 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:

Insulin resistance
Dyslipidemia
Haloperidol

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Metabolic Diseases
Psychotropic Drugs
Central Nervous System Depressants
Antiemetics
Healthy
Antipsychotic Agents
Insulin
Haloperidol

Hyperinsulinism
Haloperidol decanoate
Dopamine
Dopamine Agents
Peripheral Nervous System Agents
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Haloperidol
Hyperinsulinism
Therapeutic Uses
Dyslipidemias
Metabolic Diseases
Tranquilizing Agents
Gastrointestinal Agents

Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Haloperidol decanoate
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents
Insulin Resistance
Glucose Metabolism Disorders
Central Nervous System Agents
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009