Diabetic Nephropathy Type 2Phase 2NCT03622762
Green Tea Extract on Soluble RAGE in Patients With Diabetic Nephropathy
A Phase 2 study testing green tea extract in people with Diabetic Nephropathy Type 2, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
Trial summary
Diabetic nephropathy is one of the most feared complications of Diabetes Mellitus type 2, characterized mainly by the decrease in the glomerular filtration rate and an increase in protein secretion by the kidney, that results in proteinuria. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetic Nephropathy Type 2
- 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
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jul 2018to 20 Jun 2019
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People of both sexes
- Age from 40 to 65 years
- Signature of consent under information
- Diagnosis of type 2 diabetes mellituswith stable pharmacological treatment
- Glomerular filtration rate between 89 - 45 ml / min / 1.73 m2
- Albumin / creatinine ratio ≤ 30 - 300 mg / min
- HbA1c levels 7 - 12%
- Body mass index - 34.9
Who cannot join
- Glomerular filtration rat lower than 44 ml / min / 1.73 m2
- Albumin / creatinine ratio ≥ 300
- Other causes of kidney disease
- Other types of Diabetes
- Liver, thyroid or heart diseases
- Intolerance related to green tea or placebo components
Show all 10Show fewer
- Use of antioxidant supplements
- Active alcoholism
- Patients with pregnancy or without a safe contraceptive method
- Patients in breastfeeding period
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340
Fernando Grover Paez, PhD, (33) 10585200 ext. 34215, fgroverp@hotmail.com
Fernando Grover Paez, PhD, (33) 10585200 ext. 34215, marycruz_bp91@hotmail.com
About this study
Official title: Effect of the Administration of Green Tea Extract on Soluble RAGE and Kidney Disease in Patients With Diabetes Mellitus Type 2
Diabetic nephropathy is one of the most feared complications of Diabetes Mellitus type 2, characterized mainly by the decrease in the glomerular filtration rate and an increase in protein secretion by the kidney, that results in proteinuria. This has led to the development of intensive treatment regimens for patients with diabetes and preventive measures since once the complications have already presented the improvement of glycemic control alone may not be enough, to prevent the progression of pathological processes. Currently, interventions to delay the progression of kidney damage, include changes in lifestyle, nutritional advice and regular exercise, achieve optimal levels in glycemic control and use of pharmacological therapies with nephroprotector, angiotensin II receptor blocker (ARBs) and angiotensin-converting enzyme inhibitors (ACEIs). The most important biochemical mechanism proposed for this progression is the excessive binding of glucose to proteins, better described as the final products of advanced glycosylation (AGEs); the interaction of AGEs with its receptor (RAGE), participates in the metabolic and biochemical pathways in intracellular signaling, either by favoring or aggravating cell nephron damage. Recently, numerous RAGE isoforms have been described as: soluble RAGE, which are devoid of cytoplasmic domains, which bind to ligands that include AGEs and can antagonize intracellular signaling. Therefore, the need to seek for alternative therapies like nutraceuticals is arising, mainly due to its low toxicity and lower cost. Such is the case of green tea extract, which due to its chemical composition, especially of flavonoids that generate antioxidant and anti-inflammatory effects, In vivo and in clinical trials have shown that it could impact the progression of the diabetic neuropathy , through the modulation of the biological process, including molecular and biochemical pathways such as release of soluble RAGE.
Read the detailed description
The objective of the study is to evaluate the effect of the administration of green tea extract on soluble RAGE and renal damage in patients with Type 2 Diabetes Mellitus, by means of a clinical trial, double blind, with randomization and placebo control group. In male and female population, with a diagnosis of Diabetes Mellitus type 2, under treatment with hypoglycemic agents and / or insulin and kidney damage, 2 - 3a grade according to classification of the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines and HbA1c levels 9 - 12% who sign the letter of consent under information, from 35 to 65 years of age, residents of the metropolitan area of Guadalajara.
All patients who meet the selection criteria and who sign their informed consent will be given the clinical history, as well as anthropometric and laboratory determinations. Once these values are known, the intervention will proceed with the research product, extract of green tea 400 mg twice a day or placebo 400 mg twice a day, this will be according to the technique of masking by the closed envelope technique for 12 weeks. Patients will be evaluated at 30, 60 and 90 days of intervention, for attachment assessment, tolerability of treatment, side effects and laboratory safety determinations. At the end of the 12 weeks of the intervention, the anthropometric and laboratory determinations will be made again as well as the determination of soluble RAGE by means of Elisa sandwich type, in serum obtained at the beginning and at 12 weeks of intervention.
The database will be developed in the statistical program Statistical software (SPSS) version 21.0. The qualitative variables will be expressed in frequencies and percentages, while the quantitative variables will be expressed in means and standard deviations, the normality test will be carried out through the Kolmogorov-Smirnov test and, according to the result, it will be decided for the analysis intra group perform paired t or Wilcoxon method and for intergroup t student or Mann-Whitney U. A value of p ≤0.05 will be considered statistically significant.
- Conditions
- Diabetic Nephropathy Type 2
- Being tested
- green tea extract, Placebo
- Keywords
- Green tea extract, Kidney damage, type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green tea extractDrug
Also called Sunphenon
Capsules of green tea extract, 400 mg twice a day, fasting
PlaceboDrug
Also called Calcined magnesium
Placebo capsules, 400 mg twice daily fasting
| Study group | Role | What they receive |
|---|---|---|
| Green tea extract | Experimental | In male and female population, with a diagnosis of Diabetes Mellitus type 2, under treatment with hypoglycemic agents and / or insulin and kidney damage grade 2 - 3a according to classification of the KDIGO guidelines Receives: Drug: green tea extract |
| Placebo | Placebo comparator | In male and female population, with a diagnosis of Diabetes Mellitus type 2, under treatment with hypoglycemic agents and / or insulin and kidney damage grade 2 - 3a according to classification of the KDIGO guidelines Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soluble RAGE concentration
Before and after the intervention using the serum extracted from the patient using sandwich ELISA.
Measured: 90 days
Secondary outcomes (7)
Glomerular filtration rate
Before and after the intervention, it will be evaluated by means of a determination of serum creatinine, which will be analyzed with the spectrophotometry method and from its result the glomerular filtration rate is calculated.
Measured: 90 days
Albumin/creatinine ratio
Before and after intervention by spectrophotometry
Measured: 90 days
Fasting plasma glucose
Before and after intervention spectrophotometry
Measured: 90 days
Glycated Hemoglobin concentration
It will be analyzed by liquid chromatography
Measured: 90 days
Systolic and diastolic arterial pressure
Before and after intervention using a digital baumanometer
Measured: 90 days
Alanine aminotransferase
Before and after intervention by spectrophotometry
Measured: 90 days
Aspartate aminotransferase
Before and after intervention by spectrophotometry
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start15 Jul 2018
- Primary completion15 Mar 2019 (estimated)
- Study completion20 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Nephropathy Type 2Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Grover Paez, Centro Universitario de Ciencias de la Salud, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622762
- Sponsor's protocol ID
- CUCS-INTEC-MV-ERVE-06
- Status last verified
- Feb 2019
- First submitted
- 6 Aug 2018
- Last updated
- 20 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barocio-Pantoja M, Quezada-Fernandez P, Cardona-Muller D, Jimenez-Cazarez MB, Larios-Cardenas M, Gonzalez-Radillo OI, Garcia-Sanchez A, Carmona-Huerta J, Chavez-Guzman AN, Diaz-Preciado PA, Balleza-Alejandri R, Pascoe-Gonzalez S, Grover-Paez F. Green Tea Extract Increases Soluble RAGE and Improves Renal Function in Patients with Diabetic Nephropathy. J Med Food. 2021 Dec;24(12):1264-1270. doi: 10.1089/jmf.2020.0212. Epub 2021 Nov 17.
PubMed 34788550
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of Green Tea Extract on Soluble RAGE and Kidney Disease in Patients With Diabetes Mellitus Type 2
- ClinicalTrials.gov ID
- NCT03622762
- Acronym / sponsor ID
- CUCS-INTEC-MV-ERVE-06
- Conditions
- Diabetic Nephropathy Type 2
- Keywords
- Green tea extract, Kidney damage, type 2 diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 15 Mar 2019 (estimated)
- Study completion
- 20 Jun 2019 (estimated)
- First posted
- 9 Aug 2018 (actual)
- 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.
Diabetic nephropathy is one of the most feared complications of Diabetes Mellitus type 2, characterized mainly by the decrease in the glomerular filtration rate and an increase in protein secretion by the kidney, that results in proteinuria. This has led to the development of intensive treatment regimens for patients with diabetes and preventive measures since once the complications have already presented the improvement of glycemic control alone may not be enough, to prevent the progression of pathological processes. Currently, interventions to delay the progression of kidney damage, include changes in lifestyle, nutritional advice and regular exercise, achieve optimal levels in glycemic control and use of pharmacological therapies with nephroprotector, angiotensin II receptor blocker (ARBs) and angiotensin-converting enzyme inhibitors (ACEIs). The most important biochemical mechanism proposed for this progression is the excessive binding of glucose to proteins, better described as the final products of advanced glycosylation (AGEs); the interaction of AGEs with its receptor (RAGE), participates in the metabolic and biochemical pathways in intracellular signaling, either by favoring or aggravating cell nephron damage. Recently, numerous RAGE isoforms have been described as: soluble RAGE, which are devoid of cytoplasmic domains, which bind to ligands that include AGEs and can antagonize intracellular signaling. Therefore, the need to seek for alternative therapies like nutraceuticals is arising, mainly due to its low toxicity and lower cost. Such is the case of green tea extract, which due to its chemical composition, especially of flavonoids that generate antioxidant and anti-inflammatory effects, In vivo and in clinical trials have shown that it could impact the progression of the diabetic neuropathy , through the modulation of the biological process, including molecular and biochemical pathways such as release of soluble RAGE.
Detailed description
The objective of the study is to evaluate the effect of the administration of green tea extract on soluble RAGE and renal damage in patients with Type 2 Diabetes Mellitus, by means of a clinical trial, double blind, with randomization and placebo control group. In male and female population, with a diagnosis of Diabetes Mellitus type 2, under treatment with hypoglycemic agents and / or insulin and kidney damage, 2 - 3a grade according to classification of the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines and HbA1c levels 9 - 12% who sign the letter of consent under information, from 35 to 65 years of age, residents of the metropolitan area of Guadalajara.
All patients who meet the selection criteria and who sign their informed consent will be given the clinical history, as well as anthropometric and laboratory determinations. Once these values are known, the intervention will proceed with the research product, extract of green tea 400 mg twice a day or placebo 400 mg twice a day, this will be according to the technique of masking by the closed envelope technique for 12 weeks. Patients will be evaluated at 30, 60 and 90 days of intervention, for attachment assessment, tolerability of treatment, side effects and laboratory safety determinations. At the end of the 12 weeks of the intervention, the anthropometric and laboratory determinations will be made again as well as the determination of soluble RAGE by means of Elisa sandwich type, in serum obtained at the beginning and at 12 weeks of intervention.
The database will be developed in the statistical program Statistical software (SPSS) version 21.0. The qualitative variables will be expressed in frequencies and percentages, while the quantitative variables will be expressed in means and standard deviations, the normality test will be carried out through the Kolmogorov-Smirnov test and, according to the result, it will be decided for the analysis intra group perform paired t or Wilcoxon method and for intergroup t student or Mann-Whitney U. A value of p ≤0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green tea extract | Experimental | Drug: green tea extractIn male and female population, with a diagnosis of Diabetes Mellitus type 2, under treatment with hypoglycemic agents and / or insulin and kidney damage grade 2 - 3a according to classification of the KDIGO guidelines |
| Placebo | Placebo comparator | Drug: PlaceboIn male and female population, with a diagnosis of Diabetes Mellitus type 2, under treatment with hypoglycemic agents and / or insulin and kidney damage grade 2 - 3a according to classification of the KDIGO guidelines |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- People of both sexes
- Age from 40 to 65 years
- Signature of consent under information
- Diagnosis of type 2 diabetes mellituswith stable pharmacological treatment
- Glomerular filtration rate between 89 - 45 ml / min / 1.73 m2
Key exclusion criteria (10 listed)
- Glomerular filtration rat lower than 44 ml / min / 1.73 m2
- Albumin / creatinine ratio ≥ 300
- Other causes of kidney disease
- Other types of Diabetes
- Liver, thyroid or heart diseases
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: SunphenonCapsules of green tea extract, 400 mg twice a day, fasting | Drug | Green tea extract |
| PlaceboAlso: Calcined magnesiumPlacebo capsules, 400 mg twice daily fasting | Drug | Placebo |
Primary outcome
Soluble RAGE concentration
Time frame: 90 days
Before and after the intervention using the serum extracted from the patient using sandwich ELISA.
7 secondary outcomes
Glomerular filtration rate
Time frame: 90 days
Albumin/creatinine ratio
Time frame: 90 days
Fasting plasma glucose
Time frame: 90 days
Glycated Hemoglobin concentration
Time frame: 90 days
Systolic and diastolic arterial pressure
Time frame: 90 days
Alanine aminotransferase
Time frame: 90 days
Aspartate aminotransferase
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Derived from this study: PubMed 34788550Barocio-Pantoja M, Quezada-Fernandez P, Cardona-Muller D, Jimenez-Cazarez MB, Larios-Cardenas M, Gonzalez-Radillo OI, Garcia-Sanchez A, Carmona-Huerta J, Chavez-Guzman AN, Diaz-Preciado PA, Balleza-Alejandri R, Pascoe-Gonzalez S, Grover-Paez F. Green Tea Extract Increases Soluble RAGE and Improves Renal Function in Patients with Diabetic Nephropathy. J Med Food. 2021 Dec;24(12):1264-1270. doi: 10.1089/jmf.2020.0212. Epub 2021 Nov 17.
- Individual participant dataSharing planned: No
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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.
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 Type 2, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
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 8 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: status not confirmed, as of the sponsor's last update on 20 Feb 2019. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Grover Páez, PhD ((33) 10585200 ext. 34215, fgroverp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soluble RAGE concentration (time frame: 90 days). 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 NCT03622762, which also lists 1 linked publication.
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 20 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.