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成人糖尿病患者におけるDPP-IV阻害薬の血糖コントロールおよび自律神経障害への影響

基本情報

NCT ID
NCT01545024
ステータス
不明
試験のフェーズ
-
試験タイプ
観察
目標被験者数
60
治験依頼者名
Nagaoka Red Cross Hospital

概要

Rocca et al. reported first that the secretion of incretins, particular GLP-1 in rat is regulated by the enteric nervous system, the afferent and efferent vagus nerves \[1\]. Further, Kazakos et al. \[2\] reported that autonomic nerve disturbance (AND) in patients with T2DM impaired the incretin effect owing to decreased GLP-1 secretion. However, Toft-Nielsen et al. \[3\] reported that the decreased GLP-1 responses in the patients with type 2 diabetes mellitus (T2DM) are unlikely to be related to the AND and, thus, did not support the results of Rocca et al. and Kazakos et al. Recently, Yabe at al. \[4\] also observed the same observations in Japanese patients with T2DM. Meanwhile, Jin et al. reported that administration of DPP-IV inhibitor recovered the disturbance of diabetic nerve dysfunction in rat \[5\]. However, it is unknown whether the administration of DPP-IV inhibitor effects on the AND in human, although many studies are performed to investigate the effect of the DPP-IV inhibitors on glycemic control. Accordingly, it is significant to reinvestigate an effect of DPP-IV inhibitor on glycemic control and autonomic neuropathy in diabetic patients.

対象疾患

Type 2 Diabetes Mellitus

介入

Sitagliptin, 50 mg once per day per os(DRUG)

依頼者(Sponsor)

実施施設 (1)

長岡赤十字病院

Nagaoka, Niigata, Japan(RECRUITING)