Effect of Green Tea Extract on Lipids in Patients With Type 2 Diabetes (HDL)

August 26, 2020 updated by: Fernando Grover Paez, Centro Universitario de Ciencias de la Salud, Mexico

Effect of a 12-week Administration of Green Tea Extract on Lipids in Patients With Type 2 Diabetes

The main objectives of this study were to evaluate the effect of a 12-week supplementation with GTE (400 mg every 12 hours) on serum lipids, arterial stiffness and inflammatory cytokines in patients with T2DM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A 12 week randomized double-blind, placebo-controlled trial was conducted in patients with T2DM to evaluate the effect of green tea extract (sunphenon 90D, TAIYO international, Minneapolis, US) at a 400 mg/12 hrs dose or calcined magnesia (400 mg/12 hrs) on lipids, anthropometric variables, arterial stiffness and inflammatory cytokines.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Patients with type 2 diabetes

Exclusion Criteria:

  • Type 1 diabetes
  • Smoking patients
  • Ischemic heart disease
  • Use of anti-inflammatory or antioxidant drugs
  • Previously diagnosed liver or thyroid disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GTE
Green tea extract, 400 mg every 12 hours for 12 weeks
Dietary supplement: Green tea extract
400 mg capsule
Other Names:
  • Sunphenon 90D
PLACEBO_COMPARATOR: Placebo
Calcined magnesia, 400 mg every 12 hours for 12 weeks
Dietary supplement: Placebo
400 mg capsule
Other Names:
  • Calcined magnesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in cholesterol at week 12
Time Frame: baseline and week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
baseline and week 12
Change from baseline in HDL at week 12
Time Frame: baseline and week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
baseline and week 12
Change from baseline in LDL at week 12
Time Frame: baseline and week 12
Calculated using Friedewald's equation for LDL (LDL = cholesterol - HDL - triglycerides/5)
baseline and week 12
Change from baseline in triglycerides at week 12
Time Frame: baseline and week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
baseline and week 12
Change from baseline in VLDL at week 12
Time Frame: baseline and week 12
Calculated using Friedewald's equation for VLDL (VLDL = triglycerides/5)
baseline and week 12
Change from baseline in augmentation index at week 12
Time Frame: baseline and week 12
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
baseline and week 12
Change from baseline in pulse pressure at week 12
Time Frame: baseline and week 12
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
baseline and week 12
Change from baseline in central systolic blood pressure at week 12
Time Frame: baseline and week 12
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
baseline and week 12
Change from baseline in IL-6 at week 12
Time Frame: baseline and week 12
Measurement was done using commercially available ELISA kits from Peprotech
baseline and week 12
Change from baseline in IL-1β at week 12
Time Frame: baseline and week 12
Measurement was done using commercially available ELISA kits from Peprotech
baseline and week 12
Change from baseline in TNF-α at week 12
Time Frame: baseline and week 12
Measurement was done using commercially available ELISA kits from Peprotech
baseline and week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in glucose at week 12
Time Frame: baseline and week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
baseline and week 12
Change from baseline in Hemoglobin A1c at week 12
Time Frame: baseline and week 12
Measured using the Bio-Rad Variant Classic Hemoglobin testing system
baseline and week 12
Change from baseline in systolic blood pressure at week 12
Time Frame: baseline and week 12
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
baseline and week 12
Change from baseline in diastolic blood pressure at week 12
Time Frame: baseline and week 12
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
baseline and week 12
Change from baseline in IMC at week 12
Time Frame: baseline and week 12
Measured with the Tanita TBF-215 Body Composition Analyzer
baseline and week 12
Change from baseline in body fat percentage at week 12
Time Frame: baseline and week 12
Measured with the Tanita TBF-215 Body Composition Analyzer
baseline and week 12
Change from baseline in fat mass at week 12
Time Frame: baseline and week 12
Measured with the Tanita TBF-215 Body Composition Analyzer
baseline and week 12
Change from baseline in lean mass at week 12
Time Frame: baseline and week 12
Measured with the Tanita TBF-215 Body Composition Analyzer
baseline and week 12
Change from baseline in body water at week 12
Time Frame: baseline and week 12
Measured with the Tanita TBF-215 Body Composition Analyzer
baseline and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitario de Ciencias de la Salud, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 12, 2018

Primary Completion (ACTUAL)

January 14, 2019

Study Completion (ACTUAL)

January 14, 2019

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (ACTUAL)

August 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUCS-INTEC-MV-TEVE-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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