A Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Green Tea on Albuminuria in Patients With Diabetic Nephropathy and Use of Maximum Dose of ACE-I and / or Angiotensin II Receptor Blocker.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.
研究概览
简要总结
The purpose of this study is to determine the safety and effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.
详细描述
Clinical, prospective, randomized, double-blind, placebo-controlled, with analysis by intention to treat.
50 individuals will be selected with a diagnosis of diabetes / hypertension and has been followed in Diabetic Nephropathy Clinic of the Faculty of Medical Sciences, University of Campinas (UNICAMP). Participants are divided into 02 groups: 1) 25 patients treated with maximum dose of ACE-I and / or angiotensin II receptor blocker (ARBs) + Placebo (absence of epigallocatechin gallate) and 2) treated 25 patients with maximum dose of ACE-I and / or ARBs + green tea (epigallocatechin gallate).
The patients will receive four capsules Polyphenol E - epigallocatechin gallate (Polyphenon Pharma, NY) per day, corresponding to 800 mg of epigallocatechin gallate (EGCG), or placebo (no epigallocatechin gallate) for 3 months. Patients will not be aware of the treatment they are receiving. The subjects will be allocated for the treatment or placebo, stratified by sex. To avoid the influence of researchers, the randomization list will be generated and maintained by trained personnel in a different location from the study. Before treatment and immediately after 3 months of treatment will be obtained in the primary outcome measures (albuminuria) and secondary (plasma metabolites of flavonoids, level of urinary F2-isoprostane and 8-hydroxydeoxyguanosine). In these same times will be obtained: blood biochemistry (glucose, glycosylated hemoglobin, urea, creatinine, sodium, potassium, blood count, calcium, phosphorus, cholesterol, LDL, HDL, triglycerides, uric acid), 3 samples of first morning urine to determine albuminuria, glomerular filtration rate (GFR), blood pressure measurement of 24 h, physical examination, weight, blood pressure and heart rate. Adherence to the study will be evaluated by weekly phone and the expected increase in plasma of flavonoids using the green tea (epigallocatechin gallate). The antihypertensive drug may be adjusted to obtain the desired pressure (<130/80 mmHg).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or more
- •prior diagnosis of diabetes mellitus (DM)
- •persistent micro-or macroalbuminuria (urinary albumin excretion> 30 mg / g creatinine (AUC) in 3 consecutive measurements on different days)
- •glycated hemoglobin <10%
- •maximum dose of ACE-I and / or ARBs.
排除标准
- •diagnosis of autoimmune diseases, HIV, hepatitis, cancer, inflammatory disease
- •pregnant or lactating patients
- •glomerular filtration rate (GFR) <30 ml/min/1, 73m2 (estimated by the MDRD and the Cockcroft-Gault formula)
- •presence of kidney disease unrelated to diabetes
- •chronic urinary tract infection
- •diagnosis of congestive heart failure (CHF) New York Heart Association (NYHA) class III or IV
- •recent history (<6 months) unstable angina, myocardial infarction, stroke, coronary intervention
- •history of alcohol and / or drugs
- •mental incapacity to understand the informed consent
- •intolerance to green tea
研究组 & 干预措施
Green tea extract
Patients will receive four capsules ( one capsula = 200mg of epigallocatechin gallate) of green tea extract per day for 3 months.
干预措施: Green tea extract (Drug)
Placebo (celulose)
Patients will receive four capsules of placebo (celulose) daily for 3 months.
干预措施: Green tea extract (Drug)
结局指标
主要结局
Effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.
时间窗: After 3 months of treatment
Mean of 3 urinary albumin to creatinine ratio.
次要结局
- Effect of green tea (epigallocatechin gallate) on oxidative stress in patients with diabetic nephropathy.(After 3 months of treatment)
- Effect of green tea (epigallocatechin gallate) on plasma metabolites of flavonoids in patients with diabetic nephropathy.(After 3 months of treatment)
- Effect of green tea (epigallocatechin gallate) on blood pressure in patients with diabetic nephropathy.(After 3 months of treatment)
- Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy.(After 3 months of treatment)
- Effect of green tea (epigallocatechin gallate) on blood glucose control in patients with diabetic nephropathy.(After 3 months of tretatment)
研究者
Cynthia de Moura Borges
master's student
University of Campinas, Brazil