Arterial Stiffness Clinical Trial
Official title:
Effect of Cassia Cinnamon on Arterial Stiffness Parameters in Patients With Type 2 Diabetes Mellitus
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.
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).
The third and fourth visits (day 30 and 60) consist of evaluation of treatment adherence,
side effects, blood tests, treatment renewal and general recommendations.
The fifth and last visit (day 90) is similar to day 0 plus evaluation of treatment adherence
and side effects. This is the end of intervention period.
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