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

February 5, 2020 updated by: Sara Pascoe Gonzalez, University of Guadalajara

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Recruiting
        • Centro Universitario de Ciencias de la Salud
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cassia Cinnamon
Cassia cinnamon, capsule of 1 gram each, taken every 8 hours before meals for 90 days.
Dietary supplement: Cassia Cinnamon
Reddish - brown to light brown, typical sweet and aromatic free flowing powder.
Placebo Comparator: Calcined Magnesia
Placebo consists in calcined magnesia, capsule of 1 gram each, taken every 8 hours before meals for 90 days.
Other: Calcined magnesia
White, odor, color and flavorless thin powder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brachial - ankle pulse wave velocity
Time Frame: 90 days
Change in the pulse wave velocity
90 days
Flow mediated dilation
Time Frame: 90 days
Change in the capacity of dilation of the brachial artery
90 days
Brachial - ankle index
Time Frame: 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
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic and diastolic blood pressure
Time Frame: 4 visits: days 1, 30, 60 and 90.
Millimeters of mercury. mmHg
4 visits: days 1, 30, 60 and 90.
Blood glucose
Time Frame: 4 visits: days 1, 30, 60 and 90.
Milligrams over deciliters. mg/dL
4 visits: days 1, 30, 60 and 90.
Glycated hemoglobin
Time Frame: 4 visits: days 1, 30, 60 and 90.
Percentage
4 visits: days 1, 30, 60 and 90.
Lipid profile
Time Frame: 4 visits: days 1, 30, 60 and 90.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Investigators

  • Principal Investigator: Sandra Ofelia Hernández González, PhD, University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2018

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCRA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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