THE SAFETY AND EFFICACY OF MINOCYCLINE AS AN ANTI-PROTEINURIC IN DIABETIC NEPHRO

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 本研究的目的是找出米诺环素是否将是一种安全有效的治疗，以减少蛋白质的损失，从肾脏（在尿液中检测到）已服用高血压药物（如血管紧张素转换酶抑制剂）的II型糖尿病和糖尿病肾病受试者血管紧张素转换酶抑制剂（ACE抑制剂）和血管紧张素II阻滞剂（ARB）有助于预防或减缓糖尿病肾病的进展（恶化）。 本研究将采用前瞻性、单中心、随机、安慰剂对照设计。 共入组130例糖尿病肾病受试者。 受试者将基于基线时的平均24小时尿蛋白水平随机分组，如下：（a）<3 g/24 h和（B）>= 3 g/24 h。 研究将包括3周筛选期、基线访视（在此期间受试者将被随机分配至活性药物组（米诺环素100 mg PO BID）或匹配安慰剂组）、24周治疗期、第24周研究完成访视和完成后2个月洗脱期（重复尿液和血液测量）。 本研究将持续35周。

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. The purpose of this study is to find out whether Minocycline will be a safe and effective therapy to reduce loss of protein from the kidney (detected in the urine) in subjects with Type II Diabetes Mellitus and diabetic kidney disease who are already taking high blood pressure medications such as Angiotensin-Converting Enzyme inhibitors (ACE inhibitiors) and angiotensin II blockers (ARBs) to help prevent or slow the progression (worsening) of diabetic kidney disease. This study will use a prospective, single center, randomized, placebo-control design. A total of 130 subjects with Diabetic Nephropathy will be enrolled. Subjects will be randomized based on the mean 24 hour urine protein levels at baseline, as follows: (a) < 3g/24h and (b) >= 3g/24h. The study will consist of a 3-week screening period, a baseline visit during which the subjects will be randomly assigned to the active drug (Minocycline 100 mg PO BID) or to matching placebo, a 24-week treatment period, a study completion visit at week 24, and a 2-month post-completion washout period with repeat urine and blood measures. This study will last 35 weeks.