Diabetic NephropathyPhase 2NCT01923597
Effect of Green Tea (Epigallocatechin Gallate) on Albuminuria in Patients With Diabetic Nephropathy.
A Phase 2 study testing Green tea extract in people with Diabetic Nephropathy and Hypertension, run by University of Campinas, Brazil at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Nephropathy, Hypertension
- What is being tested?
- Green tea extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to Mar 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
The purpose of this study is to determine the safety and effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.
Read the 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).
- Conditions
- Diabetic Nephropathy, Hypertension
- Being tested
- Green tea extract
- Keywords
- Proteinuria, Oxidative stress, Epigallocatechin gallate
- Medical subject headings
- Diabetic Nephropathies, Hypertension, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green tea extractDrug
Also called Epigallocatechin gallate, Polyphenol e
200mg/capsule Administered orally 4 capsules per day For 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Green tea extract |
| Placebo (celulose) | Placebo comparator | Patients will receive four capsules of placebo (celulose) daily for 3 months. Receives: Drug: Green tea extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.
Mean of 3 urinary albumin to creatinine ratio.
Measured: After 3 months of treatment
Secondary outcomes (7)
Effect of green tea (epigallocatechin gallate) on oxidative stress in patients with diabetic nephropathy.
Urinary levels of F2-isoprostane and 8-hydroxydeoxyguanosine
Measured: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on blood glucose control in patients with diabetic nephropathy.
Glycemia and glycated hemoglobin
Measured: After 3 months of tretatment
Effect of green tea (epigallocatechin gallate) on blood pressure in patients with diabetic nephropathy.
24 h blood pressure monitoring
Measured: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy.
Plasma levels of HDL.
Measured: 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.
Measured: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy.
Plasma levels of LDL.
Measured: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy.
Plasma levels of triglycerides.
Measured: After 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia de Moura Borges, University of Campinas, Brazil
- Investigators
- José B. Lopes de Faria, MD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923597
- Sponsor's protocol ID
- Fapesp-2013
- Status last verified
- Aug 2013
- First submitted
- 13 Aug 2013
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22586583Ribaldo 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.
PubMed 19056645Borges 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.
PubMed 27320846
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01923597
- Acronym / sponsor ID
- Fapesp-2013
- Conditions
- Diabetic Nephropathy, Hypertension
- Keywords
- Proteinuria, Oxidative stress, Epigallocatechin gallate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green tea extract | Active comparator | Drug: Green tea extractPatients will receive four capsules ( one capsula = 200mg of epigallocatechin gallate) of green tea extract per day for 3 months. |
| Placebo (celulose) | Placebo comparator | Drug: Green tea extractPatients will receive four capsules of placebo (celulose) daily for 3 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green tea extractAlso: Epigallocatechin gallate, Polyphenol e200mg/capsule Administered orally 4 capsules per day For 3 months | Drug | Green tea extract, Placebo (celulose) |
Primary outcome
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.
7 secondary outcomes
Effect of green tea (epigallocatechin gallate) on oxidative stress in patients with diabetic nephropathy.
Time frame: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on blood glucose control in patients with diabetic nephropathy.
Time frame: After 3 months of tretatment
Effect of green tea (epigallocatechin gallate) on blood pressure in patients with diabetic nephropathy.
Time frame: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy.
Time frame: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma metabolites of flavonoids in patients with diabetic nephropathy.
Time frame: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy.
Time frame: After 3 months of treatment
Effect of green tea (epigallocatechin gallate) on plasma lipids in patients with diabetic nephropathy.
Time frame: After 3 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Background: PubMed 22586583Faria 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.
- Background: PubMed 19056645Ribaldo 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.
- Results publication: PubMed 27320846Borges 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.
- ResultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José B. Lopes de Faria, MD principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Green tea extract in people with Diabetic Nephropathy and Hypertension, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of green tea (epigallocatechin gallate) in albuminuria in diabetic patients and nephropathy. (time frame: After 3 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01923597, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.