The Effect of TRADJENTA ® (LINAGLIPTIN) on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- JNK-1 Protein in MNC
研究概览
简要总结
This is a single center, prospective randomized double blind, parallel and placebo controlled study to evaluate oxidative stress and inflammation before and after treatment with linagliptin for 12 weeks. We will also, testing whether Linagliptin is an insulin sensitizer.
详细描述
This is a single center, prospective randomized double blind, parallel and placebo-controlled study to evaluate oxidative stress and inflammation before and after treatment with linagliptin for 12 weeks. The study enrolls type 2 patients with diabetes.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-80 years inclusive. Type 2 diabetes BMI ≥30 kg/m2 Subjects on statins, ACE inhibitors, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the course of study.
- •HbA1c ≤ 8.0%
排除标准
- •Use of GLP-1 agonists or DPP-IV therapy in the last 3 months. History of Pancreatitis. Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and hypertriglyceridemia.
- •Subjects who are taking antiplatelet or anticoagulant medications will be excluded from the fat biopsy portion of the study.
- •Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks Hepatic disease (liver function tests more than 3 times the upper limit of normal) Renal impairment (serum eGFR <30 ml/min) Any other life-threatening, non-cardiac disease Uncontrolled hypertension (BP > 160/100 mm of Hg) Congestive Heart Failure class III or IV. Use of an investigational agent or therapeutic regimen within 30 days of study Participation in any other concurrent clinical trial
研究组 & 干预措施
Placebo
Patients will be treated for 12 weeks with placebo once daily
干预措施: Placebo (Drug)
Linagliptin 5mg per day
Patients will be treated for 12 weeks with Linagliptin 5mg once daily.
干预措施: Linagliptin (Drug)
结局指标
主要结局
JNK-1 Protein in MNC
时间窗: Week 0, Week 2, Week 4, Week 12
JNK-1 protein in MNC before and after linagliptin use as compared to placebo.
次要结局
- Oxidative Stress (as ROS Generation Level)(Week 0, Week 2, Week 4, Week 12)
- IL-1β mRNA Levels(Week 0, Week 2, Week 4, Week 12)
- Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp(At baseline and week 12)
研究者
Paresh Dandona
Principal Investigator
University at Buffalo