Clinical trial NCT04532385: Effect of Green Tea Extract on Lipids in Patients With Type 2 Diabetes
Official title: Effect of a 12-week Administration of Green Tea Extract on Lipids in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Dyslipidemias
Arterial Stiffness
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in cholesterol at week 12
timeFrame: baseline and week 12
measure: Change from baseline in HDL at week 12
timeFrame: baseline and week 12
measure: Change from baseline in LDL at week 12
timeFrame: baseline and week 12
measure: Change from baseline in triglycerides at week 12
timeFrame: baseline and week 12
measure: Change from baseline in VLDL at week 12
timeFrame: baseline and week 12
measure: Change from baseline in augmentation index at week 12
timeFrame: baseline and week 12
measure: Change from baseline in pulse pressure at week 12
timeFrame: baseline and week 12
measure: Change from baseline in central systolic blood pressure at week 12
timeFrame: baseline and week 12
measure: Change from baseline in IL-6 at week 12
timeFrame: baseline and week 12
measure: Change from baseline in IL-1β at week 12
timeFrame: baseline and week 12
measure: Change from baseline in TNF-α at week 12
timeFrame: baseline and week 12
Secondary outcomes:
measure: Change from baseline in glucose at week 12
timeFrame: baseline and week 12
measure: Change from baseline in Hemoglobin A1c at week 12
timeFrame: baseline and week 12
measure: Change from baseline in systolic blood pressure at week 12
timeFrame: baseline and week 12
measure: Change from baseline in diastolic blood pressure at week 12
timeFrame: baseline and week 12
measure: Change from baseline in IMC at week 12
timeFrame: baseline and week 12
measure: Change from baseline in body fat percentage at week 12
timeFrame: baseline and week 12
measure: Change from baseline in fat mass at week 12
timeFrame: baseline and week 12
measure: Change from baseline in lean mass at week 12
timeFrame: baseline and week 12
measure: Change from baseline in body water at week 12
timeFrame: baseline and week 12
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
state: Jalisco
Study officials:
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