Effect of Green Tea Extract on Arterial Stiffness in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      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: 
      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.
    

Intervention name(s): green tea extract; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Green tea extract capsules, 400mg 1 time daily with the first bite of eat meal; Placebo capsules, 400mg 1 time daily with the first bite of eat meal
Other intervention name(s): Sunphenon 90LB; Calcined magnesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Green tea extract; Arterial stiffness; PWVao