- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00625014
Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans
August 21, 2019 updated by: Hanno Pijl, Leiden University Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leiden, Netherlands, 2300 RC
- Leiden University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Healthy men
|
Haloperidol 3 mg/day for 8 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
February 19, 2008
First Submitted That Met QC Criteria
February 19, 2008
First Posted (Estimate)
February 28, 2008
Study Record Updates
Last Update Posted (Actual)
August 26, 2019
Last Update Submitted That Met QC Criteria
August 21, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Hyperinsulinism
- Lipid Metabolism Disorders
- Dyslipidemias
- Insulin Resistance
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Dopamine Agents
- Dopamine Antagonists
- Anti-Dyskinesia Agents
- Haloperidol
- Haloperidol decanoate
Other Study ID Numbers
- P05.009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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