Diabetic Nephropathy, Hypertension
Conditions
Keywords
Proteinuria, Oxidative stress, Epigallocatechin gallate
Brief summary
The purpose of this study is to determine the safety and effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.
Detailed description
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).
Interventions
DRUGGreen tea extract
200mg/capsule Administered orally 4 capsules per day For 3 months
Sponsors
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy. | After 3 months of treatment | Mean of 3 urinary albumin to creatinine ratio. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of green tea (epigallocatechin gallate) on oxidative stress in patients with diabetic nephropathy. | After 3 months of treatment | Urinary levels of F2-isoprostane and 8-hydroxydeoxyguanosine |
| Effect of green tea (epigallocatechin gallate) on blood glucose control in patients with diabetic nephropathy. | After 3 months of tretatment | Glycemia and glycated hemoglobin |
| Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy. | After 3 months of treatment | Plasma levels of HDL. |
| Effect of green tea (epigallocatechin gallate) on plasma metabolites of flavonoids in patients with diabetic nephropathy. | After 3 months of treatment | Plasma levels of epigallocatechin gallate and epicatechin. |
| Effect of green tea (epigallocatechin gallate) on blood pressure in patients with diabetic nephropathy. | After 3 months of treatment | 24 h blood pressure monitoring |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of Green Tea (epigallocatechin gallate) in the glomerular filtration rate in patients with diabetic nephropathy. | After 3 months of treatment | Estimated by Modification of Diet in Renal Disease (MDRD) formula. |
Countries
Brazil
Outcome results
None listed