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

NCT02627898 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-01-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

green tea extract

Green tea extract capsules, 400mg 1 time daily with the first bite of eat meal

DRUG

placebo

Placebo capsules, 400mg 1 time daily with the first bite of eat meal

Sponsors & Collaborators

  • Centro Universitario de Ciencias de la Salud, Mexico

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-09-30
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02627898 on ClinicalTrials.gov