Effect of Green Tea Extract on Arterial Stiffness in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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Type 2 diabetes mellitus (T2DM) has become the epidemic of the XXI century. This chronic disease is also highly prevalent and primarily associated with an increased cardiovascular mortality and morbidity due to micro and macrovascular complications, where its pathophysiological mechanism accelerates the formation of the atherosclerotic process, fundamental element associated with arterial stiffness. The importance of anticipating the presence of a cardiovascular event lies precisely in the early detection of subclinical changes in the elastic arteries identified by measuring the pulse wave velocity. Having adequate pharmacological or non-pharmacological interventions that impact precisely in the reduction of pulse wave velocity contributes to a reduction of cardiovascular morbidity and mortality associated with DM2. Among non-pharmacological therapies they have been studied the benefits attributed to the use of green tea infusion either encapsulated or extract have been associated mainly with anti-inflammatory and antioxidant effects. There are both experimental and clinical studies that have shown benefits of administration of green tea (extract or infusion), and administered by different routes at different dosages and for varying times. But it has been noted that not all studies with green tea meet appropriate to draw conclusions about its benefits to cardiovascular level. However, it is proposed that the use of green tea extract with a highest amount of catechins through a controlled clinical trial could be a potential therapeutic strategy for changing hemodynamic alterations and arterial stiffness favorably in this particular group of patients DM2.

Detailed Description
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The objetive is to evaluate the effect of administration of Green tea exctract on arterial stiffness in individuals with T2DM. The investigators will conduct a double-blind trial, randomized, placebo control group, each group 12 male and female patients of 35-65 years of age with T2DM, with no hypertension or treated with insulins. Randomization will determine who will receive the intervention during 8 week trial (Green tea extract capsule, 400 mg 1 time daily with the first bite of each meal or approved placebo capsules), both groups also will continue with their usual treatment. The clinical findings and laboratory test include a metabolic profile and biosafety, wich will be baseline and at 8 weeks. Body weight, body fat, body mass index (BMI) and blood pressure will be determined during the inicial and final visit, likewise, hemodynamics parameters of arterial stiffness like the aortic pulse wave velocity (PWVao), central pulse pressure (PPao), aortic augmentation index (IAxao) and central systolic blood pressure (cSBP) by an oscillometric monitoring system via BPLab ®. Adverse events and adherence to treatment will be documented. The statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. It is considered with significance at p<0.05.

Official Title
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Effect of Green Tea Extract Administration on Arterial Stiffness in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: green tea extract
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of T2DM Fasting plasma glucose >126 and <250 mg/dl at the time security Metformin monotherapy or with glibenclamide added Written informed consent Exclusion Criteria: Hypertention Treated with insulin Use of antioxidant suplements or products with caffeine Woman pregnant or breastfeeding Untreated tyroid disease Total colesterol >400mg/dl Triglycerides >400mg/dl Liver enzimes (alt and ast) more tan twice the normal range Glomerular filtration rate <60ml/min (Cockcroft-Gault)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Green tea extract<br>Individuals with T2DM controlled with metformin or glibenclamide, or both; with no hypertension neither treated with insulim | Drug: green tea extract<br>* Green tea extract capsules, 400mg 1 time daily with the first bite of eat meal<br>* Other names: Sunphenon 90LB;|
| Placebo Comparator: Placebo<br>Individuals with T2DM controlled with metformin or glibenclamide, or both; with no hypertension neither treated with insulim | Drug: placebo<br>* Placebo capsules, 400mg 1 time daily with the first bite of eat meal<br>* Other names: Calcined magnesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Aortic Pulse Wave Velocity measured in meters / second, at 12 weeks | Before and after intervention with oscillometric monitoring system via BPLab | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in aortic pulse pressure measured in mm / Hg at 12 weeks | Before and after intervention with oscillometric monitoring system via BPLab | baseline and 12 weeks | 
| Change from Baseline in aortic Augmentation index measured in percentage at 12 weeks | Before and after intervention with oscillometric monitoring system via BPLab | baseline and 12 weeks | 
| Change from Baseline in central systolic blood pressure measured in mm / Hg at 12 weeks | Before and after intervention with oscillometric monitoring system via BPLab | baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Green tea extract, Arterial stiffness, PWVao