An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Difference in the Percent Change in Fasting Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells Activation (DNA Binding Activity) in Mononuclear Cells Before and After Dapagliflozin Use
研究概览
简要总结
This is a single center, prospective, randomized, placebo -controlled, parallel design and double blind study to evaluate oxidative stress, inflammation and hypertension markers and mediators before and after treatment with dapagliflozin.
详细描述
Two groups of 26 patients each (total 52 patients) with type 2 diabetes on oral agents will be included in the study. One group will be randomized to dapagliflozin (a dose of 5 mg daily will be titrated to 10 mg daily during the first week) while the other will be placebo. The patients will be treated for 12 weeks. Only half the patients (equal numbers in both groups) will be tested for the secondary endpoints related to postprandial and single dose induced changes. The primary endpoint of the study is to detect a significant difference in the percent change in fasting Nuclear factor-k B (NFκB) activation (DNA binding activity) in mononuclear cells (MNC) before and after dapagliflozin use (0 week vs. 12 weeks) as compared to placebo.
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, ARBs, 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. -Patients will be evenly distributed between the 2 groups based on statins, -ARBs, TZDs and ACE inhibitors use.
- •HbA1c ≤ 8.0%
排除标准
- •Use of GLP-1 agonists or DPP-IV or SGLT-2 inhibitors therapy in the last 3 -months.
- •Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and -hypertriglyceridemia.
- •Coronary event or procedure (myocardial infarction, unstable angina, coronary -artery bypass, surgery or coronary angioplasty) in the previous 3 months.
- •Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver -function defined as:
- •aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or -alanine aminotransferase (ALT) >3x ULN
- •Total bilirubin >2.0 mg/dL (34.2 µmol/L)
- •Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
- •(liver function tests more than 3 times the upper limit of normal)
- •Renal impairment (serum eGFR <60 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
- •pregnant or breastfeeding patients
- •Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics
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)
Dapagliflozin
10 mg daily for the 12 weeks
干预措施: dapagliflozin (Drug)
结局指标
主要结局
Difference in the Percent Change in Fasting Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells Activation (DNA Binding Activity) in Mononuclear Cells Before and After Dapagliflozin Use
时间窗: 12 weeks
nuclear factor kappa-light-chain-enhancer of activated B cells measurement through Transcription factor assay
次要结局
- Changes in Expression of Inflammatory Mediators(12 weeks)
研究者
Paresh Dandona
distinguished professor
University at Buffalo