Healthy Male Volunteers Clinical Trial
Official title:
Influence of Treatment With Olanzapine or Ziprasidone on Transcapillary Glucose Transport in Human Skeletal Muscle
Healthy volunteers will undergo euglycaemic hyperinsulinaemic clamp and microdialysis before and after administration of 10mg olanzapine or 80mg ziprasidone during 10 days.
Background:
The efficacy of atypical antipsychotics, such as olanzapine, clozapine, risperidone,
quetiapine and ziprasidone in treating a broad spectrum of symptoms in schizophrenia as well
as their lower likelihood of extrapyramidal symptoms have led to an increased use of these
substances. However there is an ongoing debate whether treatment with atypical
antipsychotics is associated with a higher risk for metabolic abnormalities. The FDA stated
in 2003 that all atypical antipsychotics increase the risk for glucose abnormalities. For
olanzapine many, but not all studies report an increased risk for the development of
metabolic abnormalities, such as glucose intolerance, insulin-resistance and consequentially
NIDDM (Non-Insulin-Dependent-Diabetes Mellitus). Ziprasidone on the other hand seems to be
associated with a more favorable metabolic safety profile.Glucose intolerance and insulin
resistance being risk factors for the development of NIDDM and cardiovascular disease, the
exact determination of putative effects of atypical antipsychotics on insulin sensitivity
and resistance is of great need. An innovative technique, microdialysis, allows for the
measurement of various analytes in the interstitial space, i.e. to assess insulin
sensitivity directly at the responsible compartment, which is the human skeletal muscle.
With the use of microdialysis it is possible to determine the arterial to interstitial
gradient, a suitable marker for plasma glucose extraction of peripheral tissue, and thus
detect insulin resistance directly at the site of insulin action.
Aim of the study:
To compare the effects of treatment with the atypical antipsychotics olanzapine and
ziprasidone in steady-state conditions on the arterial to interstitial skeletal muscle
gradient for glucose in human skeletal muscle during euglycaemic hyperinsulinaemic clamp
conditions in male healthy volunteers.
Study design:
Open, randomized, mono-center study.
Materials and methods:
Healthy volunteers will undergo euglycaemic hyperinsulinaemic clamp and microdialysis before
and after administration of 10mg olanzapine or 80mg ziprasidone during 10 days.
Study population:
15 healthy volunteers will participate in each arm of the study, summing up to a total of 30
participants.
Main outcome variable:
The arterial to interstitial skeletal muscle glucose gradient before and during euglycaemic
hyperinsulinaemic clamp conditions, before and after administration of 10mg olanzapine or
80mg ziprasidone under steady-state conditions.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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