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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00625014
Other study ID # P05.009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2005
Est. completion date July 2005

Study information

Verified date August 2019
Source Leiden University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date July 2005
Est. primary completion date July 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Haloperidol
Haloperidol 3 mg/day for 8 days

Locations

Country Name City State
Netherlands Leiden University Medical Center Leiden

Sponsors (2)

Lead Sponsor Collaborator
Leiden University Medical Center Dutch Diabetes Research Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the effect of subchronic haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation. 8 days
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