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

L

Leiden University Medical Center (LUMC)

Status

Completed

Conditions

Insulin Resistance
Dyslipidemia

Treatments

Drug: Haloperidol

Study type

Interventional

Funder types

Other

Identifiers

NCT00625014
P05.009

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

20 to 40 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

1
Experimental group
Description:
Healthy men
Treatment:
Drug: Haloperidol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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