Effect of Cassia Cinnamon on Arterial Stiffness Parameters in Patients With Type 2 Diabetes Mellitus

  • STATUS
    Recruiting
  • days left to enroll
    40
  • participants needed
    30
  • sponsor
    University of Guadalajara
Updated on 26 February 2022

Summary

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 its 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 its 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.

Description

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.

Details
Condition Arterial Stiffness
Treatment Cassia Cinnamon, Calcined magnesia
Clinical Study IdentifierNCT04259606
SponsorUniversity of Guadalajara
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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