TARGETING INFLAMMATION USING SALSALATE FOR TYPE 2 DIABETES (TINSAL-T2D)

点击翻译按钮获取中文摘要

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Purpose: The primary objective of the study is to determine whether salicylates represent a new pharmacological option for type 2 diabetes management. The study will be conducted in two stages each having randomized prospective design. Participants: A cohort of volunteers having type 2 diabetes will consent to be randomized for Stage 1 of the study. A second cohort will be randomized for Stage 2 of the study. Procedures (methods): Stage 1 will be a double-blind placebo-controlled study of 14 wk duration, intended to determine the optimal dose of disalcid that is well tolerated and exhibits a trend toward improvement of glycemic control, in which participants are assigned in equal numbers to placebo or each of three doses of disalcid (3.0, 3.4, or 4.0 gm per day). If an optimal dose is defined, Stage 2 of the study will be conducted to determine efficacy of disalcid in achieving glycemic control, tolerability, and effect upon measures of inflammation. Stage 2 will consist of a 26 wk double blind-placebo controlled study in which participants are assigned in equal numbers to placebo or to the optimal dose of disalcid. All participants in each Stage will be observed during a placebo run-in phase. Participants will continue taking other oral agens for type 2 diabetes exacly as they had prior to the study.