JP2012533065A - 糖尿病前症及び2型糖尿病における血清アミロイドの表現型比率 - Google Patents
糖尿病前症及び2型糖尿病における血清アミロイドの表現型比率 Download PDFInfo
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Abstract
Description
本明細書で使用されている技術用語及び科学用語は全て、別様に定義されていない限り、本発明が関する分野の当業者が一般的に理解する意味を有する。本明細書で使用される場合、以下の用語は、別様に指定されていない限り、それらに帰すべき意味を有する。
実施例
ヒト血漿に由来する血清アミロイドAの表現型比率の分析
本発明の1つの例示的実施形態は、臨床的に規定された試料の集団を区別するバイオマーカー(複数可)として使用するためのSAAの表現型比率の測定である。この例示的実施形態の分析を、質量分析イムノアッセイ(MSIA)技術を使用して実施した。
びSAA−Argを半定量的に測定するための内部基準標準物質(IRS)の添加を使用した。各試料混合物は、10μLのヒト血漿、20μLの10倍希釈ウマ血清(ウマSAAはIRSである)、及び170μLのHEPES緩衝食塩水からなっていた。SAAは、抗SAA親和性ピペットチップを用いた調査により、親和性ピペットを通して試料を反復排出することによって、試料から抽出した。精製プロセスでは、HEPES緩衝食塩水を使用し、水ですすいだ後、SAA親和性回収を行った。その後、濃縮及び精製されたタンパク質を、シナピン酸MALDIマトリックスを用いて親和性ピペットから溶出し、その後の質量分析検出用にMALDI質量分析計標的に直接載せた。
それぞれ0.8360及び0.8731である。
Claims (17)
- 1つ又は複数の対象体の2型糖尿病、糖尿病前症、インスリン抵抗性、及びそれらの関連状態のうちの少なくとも1つを判定、診断、モニターすることのうちの少なくとも1つをする方法であって、SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つを分析するステップを含む方法。
- 前記SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つを分析するステップが、親SAA及びSAA−Argのうちの少なくとも1つを分析するステップを含む、請求項1に記載の方法。
- 前記SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つを分析するステップが、質量分析、クロマトグラフィー、親和性反応、ゲル電気泳動法、遠心分離、化学的方法、及び染色法のうちの少なくとも1つを実施するステップを含む、請求項1に記載の方法。
- 前記SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つを分析するステップが、単一のアッセイを実施するステップを含む、請求項1に記載の方法。
- 単一の質量分析を実施するステップを更に含む、請求項4に記載の方法。
- 対象体の糖尿病前症を診断する方法であって、前記対象体の生体試料中のSAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つのレベルを検出するステップと、前記SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つのレベルが、正常耐糖能を有する1つ又は複数の対象体に存在するレベルから統計的に有意な量調節されている場合に、糖尿病前症を有すると前記対象体を診断するステップとを含む方法。
- 前記糖尿病前症を有すると前記対象体を診断するステップが、前記SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つのレベルが、正常耐糖能を有する1つ又は複数の対象体に存在するレベルを超えて統計的に有意な量増加されている場合に、糖尿病前症を有すると前記対象体を診断するステップを含む、請求項6に記載の方法。
- 前記SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つのレベルを検出するステップが、前記親SAA及びSAA−Argのレベルを検出するステップと、前記SAAの表現型比率が、正常耐糖能を有する1つ又は複数の対象体に存在するSAAの表現型比率から統計的に有意な量調節されている場合に、糖尿病前症を有すると前記対象体を診断するステップを含む、請求項6に記載の方法。
- 前記糖尿病前症を有すると前記対象体を診断するステップが、前記SAAの表現型比率が、正常耐糖能を有する1つ又は複数の対象体に存在するSAAの表現型比率を超えて統計的に有意な量増加されている場合に、糖尿病前症を有すると前記対象体を診断するステップを含む、請求項8に記載の方法。
- 対象体の2型糖尿病を診断する方法であって、前記対象体の生体試料中のSAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つのレベルを検出するステップと、前記SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つのレベルが、正常耐糖能を有する1つ又は複数の対象体に存在するレベルから統計的に有意な量調節されている場合に、2型糖尿病を有すると前記対象体を診断するステップとを含む方法。
- 前記2型糖尿病を有すると前記対象体を診断するステップが、前記SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つのレベルが、正常耐糖能を有する1つ又は複数の対象体に存在するレベルを超えて統計的に有意な量増加されている場合に、2型糖尿病を有すると前記対象体を診断するステップを含む、請求項10に記載の方法。
- 前記SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つのレベルを検出するステップが、前記親SAA及びSAA−Argのレベルを検出するステップと、前記SAAの表現型比率が、正常耐糖能を有する1つ又は複数の対象体に存在するSAAの表現型比率から統計的に有意な量調節されている場合に、2型糖尿病を有すると前記対象体を診断するステップとを含む、請求項10に記載の方法。
- 前記2型糖尿病を有すると前記対象体を診断するステップが、前記SAAの表現型比率が、正常耐糖能を有する1つ又は複数の対象体に存在するSAAの表現型比率を超えて統計的に有意な量増加されている場合に、2型糖尿病を有すると前記対象体を診断するステップを含む、請求項12に記載の方法。
- 1つ又は複数の対象体の2型糖尿病、糖尿病前症、インスリン抵抗性、及びそれらの関連状態のうちの少なくとも1つの治療的処置を評価する方法であって、前記1つ及び/又は複数の対象体に由来する生体試料中のSAA,SAA変異体,及びSAAの表現型比率のうちの少なくとも1つをモニターするステップを含む方法。
- 前記SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つをモニターするステップが、親SAA及びSAA−Argのうちの少なくとも1つをモニターするステップを含む、請求項14に記載の方法。
- 2型糖尿病、糖尿病前症、インスリン抵抗性、及びそれらの関連状態のうちの少なくとも1つの治療的処置を特定する方法であって、前記治療的処置が、対象体内のSAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つの活性又は濃度を調節することができるかどうかを決定するステップを含む方法。
- 前記治療的処置が、SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つの活性又は濃度を調節することができるかどうかを決定するステップが、前記治療的処置が、SAA、SAA変異体、及びSAAの表現型比率のうちの少なくとも1つの活性又は濃度を調節することができるかどうかを決定するステップを含む、請求項16に記載の方法。
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