Green Tea Extract on Soluble RAGE in Patients With Diabetic Nephropathy
Effect of the Administration of Green Tea Extract on Soluble RAGE and Kidney Disease in Patients With Diabetes Mellitus Type 2
1 other identifier
interventional
30
1 country
1
Brief 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. 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.
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 Jul 2018
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
Study Start
First participant enrolled
July 15, 2018
CompletedFirst Submitted
Initial submission to the registry
August 6, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2019
CompletedFebruary 20, 2019
February 1, 2019
8 months
August 6, 2018
February 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Soluble RAGE concentration
Before and after the intervention using the serum extracted from the patient using sandwich ELISA.
90 days
Secondary Outcomes (7)
Glomerular filtration rate
90 days
Albumin/creatinine ratio
90 days
Fasting plasma glucose
90 days
Glycated Hemoglobin concentration
90 days
Systolic and diastolic arterial pressure
90 days
- +2 more secondary outcomes
Other Outcomes (5)
Total cholesterol
90 days
triglycerides
90 days
High-density lipoprotein cholesterol
90 days
- +2 more other outcomes
Study Arms (2)
Green tea extract
EXPERIMENTALIn 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 COMPARATORIn 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
Interventions
Capsules of green tea extract, 400 mg twice a day, fasting
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Use of antioxidant supplements
- Active alcoholism
- Patients with pregnancy or without a safe contraceptive method
- Patients in breastfeeding period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340, Mexico
Related Publications (1)
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.
PMID: 34788550DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigador Principal
Study Record Dates
First Submitted
August 6, 2018
First Posted
August 9, 2018
Study Start
July 15, 2018
Primary Completion
March 15, 2019
Study Completion
June 20, 2019
Last Updated
February 20, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share