Influence of Treatment With Olanzapine or Ziprasidone on Transcapillary Glucose Transport in Human Skeletal Muscle
調査の概要
状態
条件
詳細な説明
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.
研究の種類
段階
- フェーズ 4
連絡先と場所
研究場所
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Vienna、オーストリア、1090
- Department of Clinical Pharmacology, Medical University Vienna
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
協力者と研究者
捜査官
- 主任研究者:Siegfried Kasper, Prof. MD、Medical University Vienna, Department of General Psychiatry
出版物と役立つリンク
一般刊行物
- Newcomer JW, Haupt DW, Fucetola R, Melson AK, Schweiger JA, Cooper BP, Selke G. Abnormalities in glucose regulation during antipsychotic treatment of schizophrenia. Arch Gen Psychiatry. 2002 Apr;59(4):337-45. doi: 10.1001/archpsyc.59.4.337.
- Rosdahl H, Lind L, Millgard J, Lithell H, Ungerstedt U, Henriksson J. Effect of physiological hyperinsulinemia on blood flow and interstitial glucose concentration in human skeletal muscle and adipose tissue studied by microdialysis. Diabetes. 1998 Aug;47(8):1296-301. doi: 10.2337/diab.47.8.1296.
- Muller M, Holmang A, Andersson OK, Eichler HG, Lonnroth P. Measurement of interstitial muscle glucose and lactate concentrations during an oral glucose tolerance test. Am J Physiol. 1996 Dec;271(6 Pt 1):E1003-7. doi: 10.1152/ajpendo.1996.271.6.E1003.
研究記録日
主要日程の研究
研究開始
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- olanz/zipra
- EUDRACT Nr.: 2004-002147-27
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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