Green Tea Extract on Soluble RAGE in Patients With Diabetic Nephropathy

• Status: Unknown status
• Trial end date: 2019-06-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Universitario de Ciencias de la Salud, Mexico
• Treatments: Hypoglycemic Agents

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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