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

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ClinicalTrials.gov Identifier: NCT01923597
Recruitment Status : Completed
First Posted : August 15, 2013
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Cynthia de Moura Borges, University of Campinas, Brazil

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Hypertension Drug: Green tea extract Phase 2

Detailed Description:

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Green tea extract
Patients will receive four capsules ( one capsula = 200mg of epigallocatechin gallate) of green tea extract per day for 3 months.
 Drug: Green tea extract
200mg/capsule Administered orally 4 capsules per day For 3 months
Other Names:
  • Epigallocatechin gallate
  • Polyphenol e
Placebo Comparator: Placebo (celulose)
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
Other Names:
  • Epigallocatechin gallate
  • Polyphenol e


Outcome Measures
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Primary Outcome Measures :
  1. Effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy. [ Time Frame: After 3 months of treatment ]
    Mean of 3 urinary albumin to creatinine ratio.


Secondary Outcome Measures :
  1. Effect of green tea (epigallocatechin gallate) on oxidative stress in patients with diabetic nephropathy. [ Time Frame: After 3 months of treatment ]
    Urinary levels of F2-isoprostane and 8-hydroxydeoxyguanosine

  2. Effect of green tea (epigallocatechin gallate) on blood glucose control in patients with diabetic nephropathy. [ Time Frame: After 3 months of tretatment ]
    Glycemia and glycated hemoglobin

  3. Effect of green tea (epigallocatechin gallate) on blood pressure in patients with diabetic nephropathy. [ Time Frame: After 3 months of treatment ]
    24 h blood pressure monitoring

  4. Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy. [ Time Frame: After 3 months of treatment ]
    Plasma levels of HDL.

  5. Effect of green tea (epigallocatechin gallate) on plasma metabolites of flavonoids in patients with diabetic nephropathy. [ Time Frame: After 3 months of treatment ]
    Plasma levels of epigallocatechin gallate and epicatechin.

  6. Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy. [ Time Frame: After 3 months of treatment ]
    Plasma levels of LDL.

  7. Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy. [ Time Frame: After 3 months of treatment ]
    Plasma levels of triglycerides.


Other Outcome Measures:
  1. Effect of Green Tea (epigallocatechin gallate) in the glomerular filtration rate in patients with diabetic nephropathy. [ Time Frame: After 3 months of treatment ]
    Estimated by Modification of Diet in Renal Disease (MDRD) formula.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923597


Locations
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Brazil
Unicamp
Campinas, São Paulo, Brazil, 13084-971
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Principal Investigator: José B. Lopes de Faria, MD University of Campinas, Brazil
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Cynthia de Moura Borges, master's student, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01923597    
Other Study ID Numbers: Fapesp-2013
First Posted: August 15, 2013    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2013
Keywords provided by Cynthia de Moura Borges, University of Campinas, Brazil:
Proteinuria
Oxidative stress
Epigallocatechin gallate
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Albuminuria
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Proteinuria
Urination Disorders
Urological Manifestations
 Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents