新たに診断された小児1型糖尿病におけるベラパミルの臓ベータ細胞機能への影響: ランダム化臨床試験
Gregory P Forlenza1, Jennifer McVean2,3, Roy W Beck4
1Barbara Davis Center, Anschutz Medical Campus, University of Colorado, Aurora.
JAMA
|February 24, 2023
まとめ
新たに診断された1型糖尿病の子供と青少年におけるヴェラパミルの治療は,臓のベータ細胞機能を部分的に保存し,プラセボと比較して52週間でCペプチド濃度が30%増加しました.
科学分野:
- 内分泌学
- 免疫学
- 臨床薬理学
背景:
- 臓のベータ細胞におけるチオレドキシン相互作用タンパク質 (TXNIP) の過剰発現はアポトーシスを引き起こし,グルコース毒性に関与する.
- カルシウムチャネル阻害剤 (CCB) は,これらの効果を軽減する可能性があることが示され,1型糖尿病におけるベータ細胞保存の役割を示唆しています.
研究 の 目的:
- 1型糖尿病と新たに診断された小児および青少年におけるベラパミルの有効性を評価する.
主な方法:
- 新たに診断された1型糖尿病の88人の参加者 (7~17歳) を対象とした二重盲検のランダム化臨床試験.
- 参加者は52週間にわたって毎日経口ベラパミルまたはプラセボを投与された.
- 測定された主なアウトカムは,Cペプチド値 (β細胞機能のマーカー) の変化でした.
主要な成果:
- ベラパミルの治療により,プラセボと比較して52週間のCペプチド濃度が30%上昇しました (0. 65対0. 44pmol/ ml).
- プラセボ群 (71%) と比較すると,ベラパミルを投与した患者の割合がCペプチド濃度 ≥0. 2pmol/ mlを保持した割合が著しく高かった.
- ヘモグロビンA1cのレベルはグループごとに比較され,有害事象も同様でした.
結論:
- ベラパミルは,タイプ1糖尿病の子供と青少年において,52週間の間にわたって,刺激されたCペプチド分泌の部分的な保存を示した.
- これらの効果の長期的な持続性を評価し,最適な治療期間を確立するために,さらなる研究が必要である.
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