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

NCT02627898 | Completed Phase 2

• 1 other identifier: CUCS-INTEC-MV-TEVE-001
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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

Type 2 Diabetes Mellitus

Keywords

Green tea extract; Arterial stiffness; PWVao

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from Baseline in aortic pulse pressure measured in mm / Hg at 12 weeks

  baseline and 12 weeks

• Change from Baseline in aortic Augmentation index measured in percentage at 12 weeks

  baseline and 12 weeks

• Change from Baseline in central systolic blood pressure measured in mm / Hg at 12 weeks

  baseline and 12 weeks

Other Outcomes (11)

• Change from Baseline in Fasting plasma glucose measured in mg / dL at 12 weeks

  baseline and 12 weeks

• Change from Baseline in Total cholesterol measured in mg / dL at 12 weeks

  baseline and 12 weeks

• Change from Baseline in Triglycerids measured in mg / dL at 12 weeks

  baseline and 12 weeks

Study Arms (2)

Green tea extract

EXPERIMENTAL

Individuals with T2DM controlled with metformin or glibenclamide, or both; with no hypertension neither treated with insulim

Drug: green tea extract

Placebo

PLACEBO COMPARATOR

Individuals with T2DM controlled with metformin or glibenclamide, or both; with no hypertension neither treated with insulim

Drug: placebo

Interventions

green tea extract DRUG

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

Also known as: Sunphenon 90LB

Green tea extract

placebo DRUG

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

Also known as: Calcined magnesia

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of T2DM
• Fasting plasma glucose \>126 and \<250 mg/dl at the time security
• Metformin monotherapy or with glibenclamide added
• Written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centro Universitario de Ciencias de la Salud, Mexico: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Tea

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 11, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share