A Phase 2 interventional study of Green tea extract in Diabetic Nephropathy and Hypertension, sponsored by University of Campinas, Brazil. Completed at 1 site in Brazil. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-08-04.
Sponsored by University of Campinas, Brazil · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the safety and effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.
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).
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive four capsules ( one capsula = 200mg of epigallocatechin gallate) of green tea extract per day for 3 months.
Drug: Green tea extract
Patients will receive four capsules of placebo (celulose) daily for 3 months.
Drug: Green tea extract
200mg/capsule Administered orally 4 capsules per day For 3 months
Also known as: Epigallocatechin gallate, Polyphenol e
Effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.
Mean of 3 urinary albumin to creatinine ratio.
Time frame: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on oxidative stress in patients with diabetic nephropathy.
Urinary levels of F2-isoprostane and 8-hydroxydeoxyguanosine
Time frame: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on blood glucose control in patients with diabetic nephropathy.
Glycemia and glycated hemoglobin
Time frame: After 3 months of tretatment
Effect of green tea (epigallocatechin gallate) on blood pressure in patients with diabetic nephropathy.
24 h blood pressure monitoring
Time frame: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy.
Plasma levels of HDL.
Time frame: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma metabolites of flavonoids in patients with diabetic nephropathy.
Plasma levels of epigallocatechin gallate and epicatechin.
Time frame: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy.
Plasma levels of LDL.
Time frame: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy.
Plasma levels of triglycerides.
Time frame: After 3 months of treatment
Effect of Green Tea (epigallocatechin gallate) in the glomerular filtration rate in patients with diabetic nephropathy.
Estimated by Modification of Diet in Renal Disease (MDRD) formula.
Time frame: After 3 months of treatment
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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University of Campinas, Brazil