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

Primary Purpose

Insulin Resistance, Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Haloperidol
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insulin Resistance focused on measuring Insulin resistance, Dyslipidemia, Haloperidol

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Leiden University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Healthy men

Outcomes

Primary Outcome Measures

To determine the effect of subchronic haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation.

Secondary Outcome Measures

Full Information

First Posted
February 19, 2008
Last Updated
August 21, 2019
Sponsor
Leiden University Medical Center
Collaborators
Dutch Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00625014
Brief Title
Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans
Official Title
Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Dutch Diabetes Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Dyslipidemia
Keywords
Insulin resistance, Dyslipidemia, Haloperidol

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Healthy men
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Intervention Description
Haloperidol 3 mg/day for 8 days
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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