ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 61 of 668 for:    diabetes AND Hypoglycemic | Recruiting, Not yet recruiting, Available Studies

Green Tea Extract on Soluble RAGE in Patients With Diabetic Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03622762
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Fernando Grover Paez, Centro Universitario de Ciencias de la Salud, Mexico

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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Type 2 Drug: green tea extract Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of the Administration of Green Tea Extract on Soluble RAGE and Kidney Disease in Patients With Diabetes Mellitus Type 2
Actual Study Start Date : July 15, 2018
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Green tea extract
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
Drug: green tea extract
Capsules of green tea extract, 400 mg twice a day, fasting
Other Name: Sunphenon

Placebo Comparator: Placebo
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
Drug: Placebo
Placebo capsules, 400 mg twice daily fasting
Other Name: Calcined magnesium




Primary Outcome Measures :
  1. Soluble RAGE concentration [ Time Frame: 90 days ]
    Before and after the intervention using the serum extracted from the patient using sandwich ELISA.


Secondary Outcome Measures :
  1. Glomerular filtration rate [ Time Frame: 90 days ]
    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.

  2. Albumin/creatinine ratio [ Time Frame: 90 days ]
    Before and after intervention by spectrophotometry

  3. Fasting plasma glucose [ Time Frame: 90 days ]
    Before and after intervention spectrophotometry

  4. Glycated Hemoglobin concentration [ Time Frame: 90 days ]
    It will be analyzed by liquid chromatography

  5. Systolic and diastolic arterial pressure [ Time Frame: 90 days ]
    Before and after intervention using a digital baumanometer

  6. Alanine aminotransferase [ Time Frame: 90 days ]
    Before and after intervention by spectrophotometry

  7. Aspartate aminotransferase [ Time Frame: 90 days ]
    Before and after intervention by spectrophotometry


Other Outcome Measures:
  1. Total cholesterol [ Time Frame: 90 days ]
    Before and after intervention by spectrophotometry

  2. triglycerides [ Time Frame: 90 days ]
    Before and after intervention by spectrophotometry

  3. High-density lipoprotein cholesterol [ Time Frame: 90 days ]
    Before and after intervention by spectrophotometry

  4. Low-density lipoprotein cholesterol [ Time Frame: 90 days ]
    Before and after intervention by friedewall formula

  5. Weight and visceral fat % [ Time Frame: 90 days ]
    Before and after intervention using a vascula of impedance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622762


Contacts
Contact: Fernando Grover Páez, PhD (33) 10585200 ext 34215 fgroverp@hotmail.com

Locations
Mexico
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara Recruiting
Guadalajara, Jalisco, Mexico, 44340
Contact: Fernando Grover Paez, PhD    (33) 10585200 ext 34215    fgroverp@hotmail.com   
Sponsors and Collaborators
Centro Universitario de Ciencias de la Salud, Mexico

Responsible Party: Fernando Grover Paez, Investigador Principal, Centro Universitario de Ciencias de la Salud, Mexico
ClinicalTrials.gov Identifier: NCT03622762     History of Changes
Other Study ID Numbers: CUCS-INTEC-MV-ERVE-06
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fernando Grover Paez, Centro Universitario de Ciencias de la Salud, Mexico:
Green tea extract
Kidney damage
type 2 diabetes mellitus

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs