Effect of Cassia Cinnamon on Arterial Stiffness Parameters in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT04259606
Last Updated: 2020-02-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-08-17
Study Completion Date
2022-09-30
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Arterial Stiffness
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Parallel, randomized, double blind, with control group. The study consists in two groups assigned to take either cassia cinnamon or placebo. Both groups will be taken Metformin as first line therapy for type 2 diabetes mellitus
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Cassia Cinnamon
Cassia cinnamon, capsule of 1 gram each, taken every 8 hours before meals for 90 days.
Group Type
ACTIVE_COMPARATOR
Cassia Cinnamon
Intervention Type
DIETARY_SUPPLEMENT
Reddish - brown to light brown, typical sweet and aromatic free flowing powder.
Calcined Magnesia
Placebo consists in calcined magnesia, capsule of 1 gram each, taken every 8 hours before meals for 90 days.
Group Type
PLACEBO_COMPARATOR
Calcined magnesia
Intervention Type
OTHER
White, odor, color and flavorless thin powder.
Interventions
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Cassia Cinnamon
Reddish - brown to light brown, typical sweet and aromatic free flowing powder.
Intervention Type
DIETARY_SUPPLEMENT
Calcined magnesia
White, odor, color and flavorless thin powder.
Intervention Type
OTHER
Eligibility Criteria
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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.
* 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
* 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
Minimum Eligible Age
40 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Guadalajara
OTHER
Sponsor Role
lead
Responsible Party
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Sara Pascoe Gonzalez
Principal investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Sandra Ofelia Hernández González, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Guadalajara
Locations
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Centro Universitario de Ciencias de la Salud
Guadalajara, Jalisco, Mexico
Site Status
RECRUITING
Countries
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Mexico
Central Contacts
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Facility Contacts
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References
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DERIVED
Related Links
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http://pubchem.ncbi.nlm.nih.gov
Chemical properties of bark cinnamon derived Cinnamaldehyde
Other Identifiers
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CCRA
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
PHASE2/PHASE3
The Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni in Patients With Type II Diabetes Mellitus
NCT04254029
COMPLETED
PHASE4
The Effects of Cinnamon on Postprandial Blood Glucose, and Insulin in Subjects With Impaired Glucose Tolerance
NCT01027585
COMPLETED
Effect Cinnamon Spice on Postprandial Glucose and Insulin Responses
NCT04686552
COMPLETED
NA
Effect of Chia Seeds (Salvia Hispanica L.) on Glucose Control in Patients With Type 2 Diabetes
NCT00362011
COMPLETED
PHASE2
Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2
NCT03815305
UNKNOWN
PHASE4