Blockade of Receptor Cleavage in Diabetes Mellitus With an MMP Inhibitor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- MMP Activity
研究概览
简要总结
Obesity is a heightened state of inflammation in which production of cytokines and matrix metalloproteinases (MMPs) result in loss of function of insulin receptors and insulin resistance. Doxycycline (DOX) is a potent MMP inhibitor. We hypothesize that DOX will enhance insulin sensitivity and decreases inflammation in obese participants with type 2 diabetes (DM2).
详细描述
Design and Setting: 84 day (D84), double-blind, randomized, placebo (PL)-controlled clinical trial conducted in an academic tertiary care center.
Patients: Non-DM2 Controls (n=15); participants with DM2 receiving PL (n=13) or DOX (n=11).
Interventions: All participants were evaluated at day 1 (D1); those with DM2 were also evaluated at D84 after DOX 100mg twice daily or PL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ambulatory, medically stable, able to give informed consent, and comply with the protocol.
- •Obesity with BMI >30 kg/m
- •DM2 for less than 10 years.
- •7.5% < HA1C < 10%
- •Taking insulin and/or oral medications (biguanide, sulfonlylurea, etc.)
排除标准
- •Mental states that would preclude complete understanding of the protocol and compliance.
- •Chronic illness such as renal failure (with creatinine clearance <80 ml/min for Specific Aim 2).
- •Women of child-bearing age because of the potential hazard to the fetus (doxycycline may cause permanent discoloration of the teeth and deposition in bone inhibiting growth) and because doxycycline may render oral contraceptives less effective.
- •Nursing mothers.
- •Allergy to tetracyclines.
- •Subjects taking the following drugs: penicillin or it's derivatives, anticoagulant therapy, antacids containing aluminum, calcium, or magnesium, iron-containing preparations, bismuth subsalicylate, barbiturates, carbamazepine, phenytoin or methoxyflurane, thiazolidinediones (TZD)
研究组 & 干预措施
Doxycycline
Participants with DM2 receiving doxycycline 100mg BID
干预措施: Doxycycline (Drug)
Placebo
Pills prepared identical to doxycycline.
干预措施: Placebo (Other)
结局指标
主要结局
MMP Activity
时间窗: Day 84
MMP activity is measured using a charge-changing peptide substrate for MMP-2 and MMP-9. Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84.
次要结局
- CRP(Day 84)