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

Sponsor

Leiden University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00625014

Collaborator

Dutch Diabetes Research Foundation (Other)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance Dyslipidemia	Drug: Haloperidol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Mar 1, 2005

Actual Primary Completion Date :

Jul 1, 2005

Actual Study Completion Date :

Jul 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Healthy men	Drug: Haloperidol Haloperidol 3 mg/day for 8 days

Arm

Intervention/Treatment

Experimental: 1

Healthy men

Drug: Haloperidol

Haloperidol 3 mg/day for 8 days

Outcome Measures

Primary Outcome Measures

To determine the effect of subchronic haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation. [8 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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)