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Completed

NCT Number: NCT04532385

Effect 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Arterial Stiffness Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green Tea Extract

Dietary Supplement

400 mg capsule

Other names: Sunphenon 90D

Placebo

Dietary Supplement

400 mg capsule

Other names: Calcined magnesia

Primary outcomes

  1. Change from baseline in cholesterol at week 12

    Time frame: baseline and week 12

    Measured using the Erba Manheim XL-100 automatic chemistry analyzer

  2. Change from baseline in HDL at week 12

    Time frame: baseline and week 12

    Measured using the Erba Manheim XL-100 automatic chemistry analyzer

  3. 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)

  4. Change from baseline in triglycerides at week 12

    Time frame: baseline and week 12

    Measured using the Erba Manheim XL-100 automatic chemistry analyzer

  5. Change from baseline in VLDL at week 12

    Time frame: baseline and week 12

    Calculated using Friedewald's equation for VLDL (VLDL = triglycerides/5)

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Secondary outcomes

  1. Change from baseline in glucose at week 12

    Time frame: baseline and week 12

    Measured using the Erba Manheim XL-100 automatic chemistry analyzer

  2. 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

  3. 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

  4. 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

  5. Change from baseline in IMC at week 12

    Time frame: baseline and week 12

    Measured with the Tanita TBF-215 Body Composition Analyzer

  6. 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

  7. Change from baseline in fat mass at week 12

    Time frame: baseline and week 12

    Measured with the Tanita TBF-215 Body Composition Analyzer

  8. Change from baseline in lean mass at week 12

    Time frame: baseline and week 12

    Measured with the Tanita TBF-215 Body Composition Analyzer

  9. Change from baseline in body water at week 12

    Time frame: baseline and week 12

    Measured with the Tanita TBF-215 Body Composition Analyzer

Sponsors and collaborators

Lead sponsor

Centro Universitario de Ciencias de la Salud, Mexico

Other

Registry information

Official study title

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

Acronym: HDL

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2020
Registry last updated
Aug 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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