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

Primary Purpose

Diabetes Mellitus, Type 2, Dyslipidemias, Arterial Stiffness

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Green tea extract
Placebo
Sponsored by
Centro Universitario de Ciencias de la Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GTE

Placebo

Arm Description

Green tea extract, 400 mg every 12 hours for 12 weeks

Calcined magnesia, 400 mg every 12 hours for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 26, 2020
Last Updated
August 26, 2020
Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04532385
Brief Title
Effect of Green Tea Extract on Lipids in Patients With Type 2 Diabetes
Acronym
HDL
Official Title
Effect of a 12-week Administration of Green Tea Extract on Lipids in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
January 14, 2019 (Actual)
Study Completion Date
January 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario de Ciencias de la Salud, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Dyslipidemias, Arterial Stiffness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients were randomly assigned to receive green tea extract (sunphenon 90D, TAIYO international, Minneapolis, US) at a 400 mg/12 hrs dose or calcined magnesia (400 mg/12 hrs).
Masking
ParticipantInvestigator
Masking Description
An external pharmacy laboratory encapsulated the GTE and placebo, blinded and coded the study treatments.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GTE
Arm Type
Experimental
Arm Description
Green tea extract, 400 mg every 12 hours for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Calcined magnesia, 400 mg every 12 hours for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Green tea extract
Other Intervention Name(s)
Sunphenon 90D
Intervention Description
400 mg capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Calcined magnesia
Intervention Description
400 mg capsule
Primary Outcome Measure Information:
Title
Change from baseline in cholesterol at week 12
Description
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Time Frame
baseline and week 12
Title
Change from baseline in HDL at week 12
Description
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Time Frame
baseline and week 12
Title
Change from baseline in LDL at week 12
Description
Calculated using Friedewald's equation for LDL (LDL = cholesterol - HDL - triglycerides/5)
Time Frame
baseline and week 12
Title
Change from baseline in triglycerides at week 12
Description
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Time Frame
baseline and week 12
Title
Change from baseline in VLDL at week 12
Description
Calculated using Friedewald's equation for VLDL (VLDL = triglycerides/5)
Time Frame
baseline and week 12
Title
Change from baseline in augmentation index at week 12
Description
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Time Frame
baseline and week 12
Title
Change from baseline in pulse pressure at week 12
Description
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Time Frame
baseline and week 12
Title
Change from baseline in central systolic blood pressure at week 12
Description
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Time Frame
baseline and week 12
Title
Change from baseline in IL-6 at week 12
Description
Measurement was done using commercially available ELISA kits from Peprotech
Time Frame
baseline and week 12
Title
Change from baseline in IL-1β at week 12
Description
Measurement was done using commercially available ELISA kits from Peprotech
Time Frame
baseline and week 12
Title
Change from baseline in TNF-α at week 12
Description
Measurement was done using commercially available ELISA kits from Peprotech
Time Frame
baseline and week 12
Secondary Outcome Measure Information:
Title
Change from baseline in glucose at week 12
Description
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Time Frame
baseline and week 12
Title
Change from baseline in Hemoglobin A1c at week 12
Description
Measured using the Bio-Rad Variant Classic Hemoglobin testing system
Time Frame
baseline and week 12
Title
Change from baseline in systolic blood pressure at week 12
Description
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Time Frame
baseline and week 12
Title
Change from baseline in diastolic blood pressure at week 12
Description
Measured using the Omron HEM-9000AI tonometric system after resting in the sitting position for 5 minutes
Time Frame
baseline and week 12
Title
Change from baseline in IMC at week 12
Description
Measured with the Tanita TBF-215 Body Composition Analyzer
Time Frame
baseline and week 12
Title
Change from baseline in body fat percentage at week 12
Description
Measured with the Tanita TBF-215 Body Composition Analyzer
Time Frame
baseline and week 12
Title
Change from baseline in fat mass at week 12
Description
Measured with the Tanita TBF-215 Body Composition Analyzer
Time Frame
baseline and week 12
Title
Change from baseline in lean mass at week 12
Description
Measured with the Tanita TBF-215 Body Composition Analyzer
Time Frame
baseline and week 12
Title
Change from baseline in body water at week 12
Description
Measured with the Tanita TBF-215 Body Composition Analyzer
Time Frame
baseline and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Effect of Green Tea Extract on Lipids in Patients With Type 2 Diabetes

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