NCT00625014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

February 19, 2008

Last Update Submit

August 21, 2019

Conditions

Insulin ResistanceDyslipidemia

Keywords

Insulin resistanceDyslipidemiaHaloperidol

Outcome Measures

Primary Outcomes (1)

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

    8 days

Study Arms (1)

1

EXPERIMENTAL

Healthy men

Drug: Haloperidol

Interventions

HaloperidolDRUG

Haloperidol 3 mg/day for 8 days

1

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men
  • kg/m2 \< BMI \< 26 kg/m2
  • Age 20-40 years
  • FPG \< 6 mmol/L

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

MeSH Terms

Conditions

Insulin ResistanceDyslipidemias

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof dr H Pijl

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 28, 2008

Study Start

March 1, 2005

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

August 26, 2019

Record last verified: 2019-08

Locations

NL(1)