Effect of Cassia Cinnamon on Arterial Stiffness Parameters in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Brachial - ankle pulse wave velocity
研究概览
简要总结
Type 2 diabetes mellitus is considered a serious public health problem that has been raising worldwide. In Mexico, it is an important cause of morbi - mortality and it´s characterized by hyperglycemia that promotes an increase of cardiovascular risk through the impairment of arterial stiffness and endothelial function, which, in a chronic manner promotes the development of micro and macrovascular complications.
Many nutraceuticals have been currently implemented aimed to improve glycemic control, and reduce cardiovascular risk and it´s complications, which results in a better quality of life in patients with type 2 diabetes mellitus.
Cassia cinnamon pulverized bark has demonstrated to have vasodilator effect independent of endothelial mechanisms, probably regulating calcium influx or release into or within the cell, the later demonstrated in mice.
详细描述
A randomized, placebo control group, double blind clinical trial. 30 patients (male or female) from 40 to 65 years old with type 2 diabetes mellitus, less than 1 year of diagnosis, taking Metformin 850 mg daily, referred to the Experimental and Clinical Therapeutic Institute will be included.
All patients should give written informed consent prior to be enrolled. The protocol was previously approved by the local ethics committee (Experimental and Clinical Therapeutic Institute) of University of Guadalajara, registration number: CEI/489/2019. Patients with other medical conditions, taking additional drugs or with more than 1 year of evolution will be excluded.
Procedure:
The entire study consists of a total of 5 visits, the first one (day - 7) is the screening visit where written informed consent, clinical history, anthropometric measurements and blood samples will be performed.
The second or initial visit (day 0) consists of review of laboratory results, hemodynamic studies (i.e brachial - ankle pulse wave velocity and index for arterial stiffness and flow mediated dilation on brachial artery for endothelial function with VP1000 and UNEX EF devices respectively), and after randomization, start of intervention (either cassia cinnamon or placebo).
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)
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
- •Written informed consent prior to the beginning of enrollment
- •Men and women 40 to 65 years old
- •Diagnosis of type 2 diabetes mellitus according to the American Diabetes Association criteria
- •Fasting plasma glucose ≥ 126 mg/dl (7.0 mmol/L) at least 8 h of fasting
- •Plasma glucose ≥ 200 mg/dl (11.1 mmol/L) 2 hours after oral glucose tolerance test
- •HbA1c ≥ 6.5 % (48 mmol/mol)
- •Plasma glucose ≥ 200 mg/dl (11.1 mmol/L) in a random glucose test with typical symptoms of hyperglucemia or hyperglycemic crisis.
排除标准
- •HbA1c < 6.5 % or > 10 % or fasting glucose plasma > 250 mg/dl
- •Total serum cholesterol ≥ 240 mg/dl
- •Triglycerides ≥ 400 mg/dl
- •History of allergy to any of the components used in the study
- •Consumption of additional drugs with known effects on glucose and lipids metabolism and weight reduction
- •History of cardiovascular disease, blood abnormalities and/or kidney, pancreatic or thyroid disease
- •Childbearing and breastfeeding women
- •History of smoking within 12 months prior to beginning of study
- •History of drug abuse and alcoholism
- •Pacemaker bearing or any other permanent bioelectronic device that could modify or interfere with electrical bioimpedance tests
结局指标
主要结局
Brachial - ankle pulse wave velocity
时间窗: 90 days
Change in the pulse wave velocity
Brachial - ankle index
时间窗: 90 days
Change in the systolic and diastolic pressures of the brachial and tibial arteries, the index is the result of dividing the last between the first
Flow mediated dilation
时间窗: 90 days
Change in the capacity of dilation of the brachial artery
次要结局
- Glycated hemoglobin(4 visits: days 1, 30, 60 and 90.)
- Lipid profile(4 visits: days 1, 30, 60 and 90.)
- Systolic and diastolic blood pressure(4 visits: days 1, 30, 60 and 90.)
- Blood glucose(4 visits: days 1, 30, 60 and 90.)
研究者
Sara Pascoe Gonzalez
Principal investigator
University of Guadalajara