Effect of Green Tea (Epigallocatechin Gallate) on Albuminuria in Patients With Diabetic Nephropathy.
Launched by UNIVERSITY OF CAMPINAS, BRAZIL · Aug 13, 2013
Trial Information
Current as of May 14, 2025
Completed
Keywords
ClinConnect Summary
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 gallat...
Gender
ALL
Eligibility 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
About University Of Campinas, Brazil
The University of Campinas (Universidade Estadual de Campinas, UNICAMP) is a prestigious research institution located in Brazil, renowned for its commitment to advancing knowledge and innovation in the medical and scientific fields. With a strong emphasis on interdisciplinary collaboration, UNICAMP conducts cutting-edge clinical trials aimed at improving healthcare outcomes and developing novel therapeutic approaches. The university leverages its extensive resources, including state-of-the-art laboratories and a team of highly qualified researchers and clinicians, to contribute significantly to the global body of medical research while fostering education and training in clinical and translational sciences.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Campinas, São Paulo, Brazil
Patients applied
Trial Officials
José B. Lopes de Faria, MD
Principal Investigator
University of Campinas, Brazil
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials