Green Tea Extract on Soluble RAGE in Patients With Diabetic Nephropathy

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.