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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项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方法，以减少II型糖尿病和糖尿病肾病患者的肾脏蛋白质损失(在尿液中检测到)，这些患者已经在服用血管紧张素转换酶抑制剂(ACE抑制剂)和血管紧张素II受体阻滞剂(ARB)等高血压药物，以帮助预防或减缓糖尿病肾脏疾病的进展(恶化)。 本研究将采用前瞻性、单中心、随机、安慰剂对照设计。 共有130名糖尿病肾病患者入选。 受试者将根据基线时的平均24小时尿蛋白水平进行随机分组，如下：(A)&lt；3g/24和(B)&gt；=3g/24。 这项研究将包括3周的筛查期、基线访问，在此期间，受试者将被随机分配到活性药物(米诺环素100毫克，口服Bid)或与之匹配的安慰剂中，24周的治疗期，24周的研究完成访问，以及2个月的完成后的洗涤期，重复进行尿液和血液测量。 这项研究将持续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.