Effect of Green Tea (Epigallocatechin Gallate) on Albuminuria in Patients With Diabetic Nephropathy.

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Campinas, Brazil
• Treatments: Angiotensin Receptor Antagonists; Epigallocatechin gallate

Criteria

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