Effect of a 12-week Administration of Green Tea Extract on Lipids in Patients With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change from baseline in cholesterol at week 12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
An external pharmacy laboratory encapsulated the GTE and placebo, blinded and coded the study treatments.
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Calcined magnesia, 400 mg every 12 hours for 12 weeks
Intervention: Placebo (Dietary Supplement)
GTE
Green tea extract, 400 mg every 12 hours for 12 weeks
Intervention: Green tea extract (Dietary Supplement)
Outcomes
Primary Outcomes
Change from baseline in cholesterol at week 12
Time Frame: baseline and week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
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
Change from baseline in HDL at week 12
Time Frame: baseline and week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Change from baseline in triglycerides at week 12
Time Frame: baseline and week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Change from baseline in VLDL at week 12
Time Frame: baseline and week 12
Calculated using Friedewald's equation for VLDL (VLDL = triglycerides/5)
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
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)
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
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
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
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
- Change from baseline in glucose at week 12(baseline and week 12)
- Change from baseline in Hemoglobin A1c at week 12(baseline and week 12)
- Change from baseline in diastolic blood pressure at week 12(baseline and week 12)
- Change from baseline in IMC at week 12(baseline and week 12)
- Change from baseline in lean mass at week 12(baseline and week 12)
- Change from baseline in body water at week 12(baseline and week 12)
- Change from baseline in systolic blood pressure at week 12(baseline and week 12)
- Change from baseline in body fat percentage at week 12(baseline and week 12)
- Change from baseline in fat mass at week 12(baseline and week 12)
Investigators
Fernando Grover Paez
Profesor Investigador Titular A
Centro Universitario de Ciencias de la Salud, Mexico