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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Green tea extract | Active Comparator | Patients will receive four capsules ( one capsula = 200mg of epigallocatechin gallate) of green tea extract per day for 3 months. |
|
| Placebo (celulose) | Placebo Comparator | Patients will receive four capsules of placebo (celulose) daily for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green tea extract | Drug | 200mg/capsule Administered orally 4 capsules per day For 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy. | Mean of 3 urinary albumin to creatinine ratio. | After 3 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of green tea (epigallocatechin gallate) on oxidative stress in patients with diabetic nephropathy. | Urinary levels of F2-isoprostane and 8-hydroxydeoxyguanosine | After 3 months of treatment |
| Effect of green tea (epigallocatechin gallate) on blood glucose control in patients with diabetic nephropathy. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 3 months of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José B. Lopes de Faria, MD | University of Campinas, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unicamp | Campinas | São Paulo | 13084-971 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22586583 | Background | Faria AM, Papadimitriou A, Silva KC, Lopes de Faria JM, Lopes de Faria JB. Uncoupling endothelial nitric oxide synthase is ameliorated by green tea in experimental diabetes by re-establishing tetrahydrobiopterin levels. Diabetes. 2012 Jul;61(7):1838-47. doi: 10.2337/db11-1241. Epub 2012 May 14. | |
| 19056645 | Background |
| Label | URL |
|---|---|
| Results | View source |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D006973 | Hypertension |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D013662 | Tea |
| C045651 | epigallocatechin gallate |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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Glycemia and glycated hemoglobin |
| After 3 months of tretatment |
| Effect of green tea (epigallocatechin gallate) on blood pressure in patients with diabetic nephropathy. | 24 h blood pressure monitoring | After 3 months of treatment |
| Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy. | Plasma levels of HDL. | 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. | After 3 months of treatment |
| Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy. | Plasma levels of LDL. | After 3 months of treatment |
| Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy. | Plasma levels of triglycerides. | After 3 months of treatment |
| Ribaldo PD, Souza DS, Biswas SK, Block K, Lopes de Faria JM, Lopes de Faria JB. Green tea (Camellia sinensis) attenuates nephropathy by downregulating Nox4 NADPH oxidase in diabetic spontaneously hypertensive rats. J Nutr. 2009 Jan;139(1):96-100. doi: 10.3945/jn.108.095018. Epub 2008 Dec 3. |
| 27320846 | Result | Borges CM, Papadimitriou A, Duarte DA, Lopes de Faria JM, Lopes de Faria JB. The use of green tea polyphenols for treating residual albuminuria in diabetic nephropathy: A double-blind randomised clinical trial. Sci Rep. 2016 Jun 20;6:28282. doi: 10.1038/srep28282. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |