Effect of Green Tea (Epigallocatechin Gallate) on Albuminuria in Patients With Diabetic Nephropathy.
A Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Green Tea on Albuminuria in Patients With Diabetic Nephropathy and Use of Maximum Dose of ACE-I and / or Angiotensin II Receptor Blocker.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2013
CompletedFirst Posted
Study publicly available on registry
August 15, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedAugust 4, 2016
August 1, 2013
1.3 years
August 13, 2013
August 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
Effect of green tea (epigallocatechin gallate) on oxidative stress in patients with diabetic nephropathy.
After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on blood glucose control in patients with diabetic nephropathy.
After 3 months of tretatment
Effect of green tea (epigallocatechin gallate) on blood pressure in patients with diabetic nephropathy.
After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy.
After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma metabolites of flavonoids in patients with diabetic nephropathy.
After 3 months of treatment
- +2 more secondary outcomes
Other Outcomes (1)
Effect of Green Tea (epigallocatechin gallate) in the glomerular filtration rate in patients with diabetic nephropathy.
After 3 months of treatment
Study Arms (2)
Green tea extract
ACTIVE COMPARATORPatients will receive four capsules ( one capsula = 200mg of epigallocatechin gallate) of green tea extract per day for 3 months.
Placebo (celulose)
PLACEBO COMPARATORPatients will receive four capsules of placebo (celulose) daily for 3 months.
Interventions
200mg/capsule Administered orally 4 capsules per day For 3 months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unicamp
Campinas, São Paulo, 13084-971, Brazil
Related Publications (3)
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.
PMID: 22586583BACKGROUNDRibaldo 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.
PMID: 19056645BACKGROUNDBorges 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.
PMID: 27320846RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José B. Lopes de Faria, MD
University of Campinas, Brazil
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- master's student
Study Record Dates
First Submitted
August 13, 2013
First Posted
August 15, 2013
Study Start
November 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
August 4, 2016
Record last verified: 2013-08