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

Arterial Stiffness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04259606
• Other study ID #: CCRA
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2018
• Est. completion date: September 2022

Study information

• Verified date: February 2020
• Source: University of Guadalajara
• Contact: Sara Pascoe González, PhD
• Phone: 3331370639
• Email: spg0371[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Stiffness
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Cassia Cinnamon
Reddish - brown to light brown, typical sweet and aromatic free flowing powder.

Other:
• Calcined magnesia
White, odor, color and flavorless thin powder.

Locations

Country	Name	City	State
Mexico	Centro Universitario de Ciencias de la Salud	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

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* Note: There are 56 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial - ankle pulse wave velocity	Change in the pulse wave velocity	90 days
Primary	Flow mediated dilation	Change in the capacity of dilation of the brachial artery	90 days
Primary	Brachial - ankle index	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	90 days
Secondary	Systolic and diastolic blood pressure	Millimeters of mercury. mmHg	4 visits: days 1, 30, 60 and 90.
Secondary	Blood glucose	Milligrams over deciliters. mg/dL	4 visits: days 1, 30, 60 and 90.
Secondary	Glycated hemoglobin	Percentage	4 visits: days 1, 30, 60 and 90.
Secondary	Lipid profile	Total cholesterol, triglycerides, high density lipoprotein, very high density lipoprotein, low density lipoprotein. All of them expressed in milligrams over deciliters. mg/dL	4 visits: days 1, 30, 60 and 90.

External Links

•   Chemical properties of bark cinnamon derived Cinnamaldehyde