The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Reactive Oxygen Species (ROS) Generation by MNC, Protein and mRNA Expression of p47phox Subunit of NADPH Oxidase, in MNC's of Obese Type 2 Diabetic Patients
研究概览
简要总结
Sitagliptin is a new oral hypoglycemic anti-diabetic drug used either alone or in combination with metformin or a thiazolidinedione for control of type 2 diabetes mellitus. Sitagliptin has been shown to have fewer side effects in the control of blood glucose values.
Obesity and diabetes are states of increased inflammation and can influence the free radicals and inflammatory markers (chemicals in the blood which increase due to inflammation in the body) and are also major risk factors for atherosclerotic disease. In this study we want to see the effect of sitagliptin on these markers. We believe that Sitagliptin may exert an anti-inflammatory effect in the human. The purpose of this study is to determine if the addition of sitagliptin to diabetic patients will provide added benefit. We believe that sitagliptin provides these added benefits by suppressing free radicals (charged substances that cause damage to the body) and inflammation.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females with age 20-75 years inclusive.
- •Type 2 diabetes
- •Males and Females BMI > 30
- •Subjects on statins, ACE inhibitors, thiazolidenediones 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.
- •BP under control -No change required to BP medications
- •HbA1c > 7%
排除标准
- •Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
- •Pregnancy
- •Hepatic disease (abnormal LFT's),Renal impairment (serum creatinine > 1.5),
- •Participation in any other concurrent clinical trial
- •Any other life-threatening, non-cardiac disease,
- •Uncontrolled hypertension (BP > 160/100 mm of Hg)
- •Congestive Heart Failure
- •Use of an investigational agent or therapeutic regimen within 30 days of study
- •Subjects on Exenatide, incretin or insulin therapy
研究组 & 干预措施
Januvia 100mg
The first group will be started on 100 mg sitagliptin daily for 12 weeks
干预措施: Januvia (Sitagliptin) 100 mg (Drug)
placebo
will be placed on a placebo for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Reactive Oxygen Species (ROS) Generation by MNC, Protein and mRNA Expression of p47phox Subunit of NADPH Oxidase, in MNC's of Obese Type 2 Diabetic Patients
时间窗: 12 weeks
次要结局
- Change in Oxidative Stress From Baseline to 12 Weeks(value at 12 weeks minus value at baseline)