Arterial Stiffness, Diabetes Mellitus, Type 2, Dyslipidemias
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGreen tea extract
400 mg capsule
DIETARY_SUPPLEMENTPlacebo
400 mg capsule
Sponsors
Centro Universitario de Ciencias de la Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
An external pharmacy laboratory encapsulated the GTE and placebo, blinded and coded the study treatments.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in TNF-α at week 12 | baseline and week 12 | Measurement was done using commercially available ELISA kits from Peprotech |
| Change from baseline in HDL at week 12 | baseline and week 12 | Measured using the Erba Manheim XL-100 automatic chemistry analyzer |
| Change from baseline in LDL at week 12 | baseline and week 12 | Calculated using Friedewald's equation for LDL (LDL = cholesterol - HDL - triglycerides/5) |
| Change from baseline in triglycerides at week 12 | baseline and week 12 | Measured using the Erba Manheim XL-100 automatic chemistry analyzer |
| Change from baseline in VLDL at week 12 | baseline and week 12 | Calculated using Friedewald's equation for VLDL (VLDL = triglycerides/5) |
| Change from baseline in augmentation index at week 12 | 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 | 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 central systolic blood pressure at week 12 | 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 IL-6 at week 12 | baseline and week 12 | Measurement was done using commercially available ELISA kits from Peprotech |
| Change from baseline in IL-1β at week 12 | baseline and week 12 | Measurement was done using commercially available ELISA kits from Peprotech |
| Change from baseline in cholesterol at week 12 | baseline and week 12 | Measured using the Erba Manheim XL-100 automatic chemistry analyzer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Hemoglobin A1c at week 12 | baseline and week 12 | Measured using the Bio-Rad Variant Classic Hemoglobin testing system |
| Change from baseline in systolic blood pressure at week 12 | 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 diastolic blood pressure at week 12 | 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 IMC at week 12 | baseline and week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer |
| Change from baseline in body fat percentage at week 12 | baseline and week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer |
| Change from baseline in fat mass at week 12 | baseline and week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer |
| Change from baseline in lean mass at week 12 | baseline and week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer |
| Change from baseline in body water at week 12 | baseline and week 12 | Measured with the Tanita TBF-215 Body Composition Analyzer |
| Change from baseline in glucose at week 12 | baseline and week 12 | Measured using the Erba Manheim XL-100 automatic chemistry analyzer |
Countries
Mexico
Outcome results
None listed