Effect of a 12-week Administration of Green Tea Extract on Lipids in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline in cholesterol at week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
An external pharmacy laboratory encapsulated the GTE and placebo, blinded and coded the study treatments.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes
排除标准
- •Type 1 diabetes
- •Smoking patients
- •Ischemic heart disease
- •Use of anti-inflammatory or antioxidant drugs
- •Previously diagnosed liver or thyroid disease
研究组 & 干预措施
Placebo
Calcined magnesia, 400 mg every 12 hours for 12 weeks
干预措施: Placebo (Dietary Supplement)
GTE
Green tea extract, 400 mg every 12 hours for 12 weeks
干预措施: Green tea extract (Dietary Supplement)
结局指标
主要结局
Change from baseline in cholesterol at week 12
时间窗: baseline and week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Change from baseline in IL-6 at week 12
时间窗: baseline and week 12
Measurement was done using commercially available ELISA kits from Peprotech
Change from baseline in HDL at week 12
时间窗: baseline and week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Change from baseline in triglycerides at week 12
时间窗: baseline and week 12
Measured using the Erba Manheim XL-100 automatic chemistry analyzer
Change from baseline in VLDL at week 12
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: baseline and week 12
Measurement was done using commercially available ELISA kits from Peprotech
Change from baseline in augmentation index at week 12
时间窗: 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
时间窗: 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
时间窗: baseline and week 12
Measurement was done using commercially available ELISA kits from Peprotech
次要结局
- 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)
研究者
Fernando Grover Paez
Profesor Investigador Titular A
Centro Universitario de Ciencias de la Salud, Mexico