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

Tracking Information
First Received Date ^ICMJE	February 19, 2008
Last Updated Date	February 19, 2008
Start Date ^ICMJE	March 2005
Primary Completion Date	July 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 19, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans
Official Title ^ICMJE	Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans
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.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Other, Open Label, Single Group Assignment
Condition ^ICMJE	Insulin Resistance Dyslipidemia
Intervention ^ICMJE	Drug: Haloperidol
Study Arms / Comparison Groups	Experimental: Healthy men
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	8
Completion Date	July 2005
Primary Completion Date	July 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Male
Ages	20 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT ID ^ICMJE	NCT00625014
Responsible Party	Prof H Pijl, Leiden University Medical Center
Study ID Numbers ^ICMJE	P05.009
Study Sponsor ^ICMJE	Leiden University Medical Center
Collaborators ^ICMJE	Dutch Diabetes Foundation
Investigators ^ICMJE
Information Provided By	Leiden University Medical Center
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP