Influence of treatment of olanzapine and ziprasidone on transcapillary glucose transport in human skeletal muscle - Olanzapine or ziprasidone on transcapillary glucose transport

• Conditions: Healthy volunteers

• Registration Number: EUCTR2004-002147-27-AT
• Lead Sponsor: Department of General Psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-21
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

-Age between 18-55
-Healthy male volunteers
-No history of drug or alcohol abuse
-No regular nicotine consumption at time of enrollment
-Physical activity at least twice a week
-Body mass Index between 19-24 kg/m2
-Normal laboratory values
-Normotension (blood pressure less than 140/90)
-No past or present history of psychiatric disorder
-No family history of diabetes or obesity
-Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Use of medication within the last 14 days
-Consumption of alcohol within the last 5 days
-Family history of diabetes or obesity
-Past or present psychiatric disorder

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effects of treatment with the atypical antipsychotics olanzapine and ziprasidone in steady-state conditions on the arterial to interstital skeletal muscle gradient for glucose in human skeletal muscle during euglycaemic hyperinsulinaemic clamp conditions in male healthy volunteers.;Secondary Objective: ;Primary end point(s): The arterial to interstitial skeletal muscle glucose gradient before and during euglycaemic hyperinsulinaemic clamp conditions. This gradient will be measured before and after administration of 10 mg olanzapine or 80 mg ziprasidone in steady-state conditions. Endpoint will be set after second euglycaemic hyperinsulinaemic clamp and microdialysis.