Reducing Plasma Glucose Effect of Cinnamon in Type 2 Diabetic Patients in the Municipality of Comasagua
NCT ID: NCT03711682
Last Updated: 2020-11-09
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
COMPLETED
Clinical Phase
PHASE2/PHASE3
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-03-01
Study Completion Date
2018-05-23
Brief Summary
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The aim of the study is evaluate the effect of cinnamon powder (Cinnamomum verum) on the glycaemia and HbA1c (Glycohemoglobin) of type 2 diabetic Salvadoran patients, whose hypoglycemic treatment is only Metformin. To carry out this objective, subjects who agree to be part of the study will subjected to measurements of their body weight, height, body mass index, waist circumference, systolic pressure, diastolic pressure, capillary glucose (with glucose meter) every 2 weeks, and their glycohemoglobin (HbA1c) at the beginning and at the end of the study.
Detailed Description
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The study will be conducted for 12 weeks (3 months) with 30 participants diagnosed with type 2 diabetes mellitus, whose only treatment for diabetes is metformin.
Both, intervention with Cinnamon (Cinnamomum verum) and wheat flour (placebo) will be encapsulated in titanium white capsules with 500 mg of powder, that will take place in agro-industry laboratories, and will be packed in glass bottles with a content of 56 capsules and a bag of silica gel.
The data of the probable participants will verified with their medical records in the Intermediate Communitarian Unit of Family Health of Comasagua municipality (UCSFI-Comasagua). Then those who meet the criteria will contacted to be enrolled in the study, if they agreed, an informed consent will signed or stamped if the participant cannot read and write.
The randomization will be make using a list of the participants and them using the Graphpad QuickCalcs option of "Randomly assign participants to groups", assigning the participants to a group A (intervention) or B (placebo).
Participants in both groups will continue to receive the treatment they would normally receive from their respective primary care providers during the duration of the study.
The participants, who accepted and signed the informed consent, will provided with a moth calendar with the schedule of the measures. The measured variables are body weight, height, body mass index, waist circumference, systolic pressure, diastolic pressure, capillary glucose (with glucose meter) and HbA1c. The measurements will take place every 2 weeks (week 0, 2, 4, 6, 8, 10 and 12) with the exception of HbA1c which will be measured at the beginning and at the end of the study (week 0 and 12).
The obtained data will be write in the paper medical records of each participant and then exported to a database in Microsoft Excel, after that data will processed in statistical software. In case of adverse effects, this will recorded into a formulary dedicated to it, this provided to the UCSFI-Comasagua physicians with the contact data of the researchers. In addition, to perform this study the researchers make an agreement with the UCSFI-Comasagua and with the endocrinology service of the Rosales National Hospital along with the Salvadoran Association of Diabetes (ASADI) to provide health care and support to those participants who presented adverse effects.
Both, intervention with Cinnamon (Cinnamomum verum) and wheat flour (placebo) will be encapsulated in titanium white capsules with 500 mg of powder, that will take place in agro-industry laboratories, and will be packed in glass bottles with a content of 56 capsules and a bag of silica gel.
The data of the probable participants will verified with their medical records in the Intermediate Communitarian Unit of Family Health of Comasagua municipality (UCSFI-Comasagua). Then those who meet the criteria will contacted to be enrolled in the study, if they agreed, an informed consent will signed or stamped if the participant cannot read and write.
The randomization will be make using a list of the participants and them using the Graphpad QuickCalcs option of "Randomly assign participants to groups", assigning the participants to a group A (intervention) or B (placebo).
Participants in both groups will continue to receive the treatment they would normally receive from their respective primary care providers during the duration of the study.
The participants, who accepted and signed the informed consent, will provided with a moth calendar with the schedule of the measures. The measured variables are body weight, height, body mass index, waist circumference, systolic pressure, diastolic pressure, capillary glucose (with glucose meter) and HbA1c. The measurements will take place every 2 weeks (week 0, 2, 4, 6, 8, 10 and 12) with the exception of HbA1c which will be measured at the beginning and at the end of the study (week 0 and 12).
The obtained data will be write in the paper medical records of each participant and then exported to a database in Microsoft Excel, after that data will processed in statistical software. In case of adverse effects, this will recorded into a formulary dedicated to it, this provided to the UCSFI-Comasagua physicians with the contact data of the researchers. In addition, to perform this study the researchers make an agreement with the UCSFI-Comasagua and with the endocrinology service of the Rosales National Hospital along with the Salvadoran Association of Diabetes (ASADI) to provide health care and support to those participants who presented adverse effects.
Conditions
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Type 2 Diabetes Mellitus
Keywords
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Type 2 diabetes mellitus
Glucose
Cinnamomum verum
Cinnamomum zeylanicum
Cinnamon
HbA1c
Blood Pressure
Glycated Hemoglobin
Diastolic Pressure
Systolic Pressure
Body Mass Index
BMI
Metformin
Waist Circumference
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Caregivers
Study Groups
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Cinnamon (Intervented)
Group Type
EXPERIMENTAL
Cinnamon
Intervention Type
DIETARY_SUPPLEMENT
Participants in this group will receive cinnamon capsules for 12 weeks period. With a 2 g dose in capsules with 500 mg of cinnamon powder (Cinnamomum verum), 1 g in during the breakfast (2 capsules) and the other 1 g (2 capsules) during the dinner.
Wheat Flour (Placebo)
Group Type
PLACEBO_COMPARATOR
Wheat Flour
Intervention Type
DIETARY_SUPPLEMENT
Participants in this group will receive placebo capsules for 12 weeks period. With a 2 g dose in capsules with 500 mg of wheat flour(fortified with iron, niacin, thiamin, riboflavin and folic acid), 1 g in during the breakfast (2 capsules) and the other 1 g (2 capsules) during the dinner.
Interventions
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Cinnamon
Participants in this group will receive cinnamon capsules for 12 weeks period. With a 2 g dose in capsules with 500 mg of cinnamon powder (Cinnamomum verum), 1 g in during the breakfast (2 capsules) and the other 1 g (2 capsules) during the dinner.
Intervention Type
DIETARY_SUPPLEMENT
Wheat Flour
Participants in this group will receive placebo capsules for 12 weeks period. With a 2 g dose in capsules with 500 mg of wheat flour(fortified with iron, niacin, thiamin, riboflavin and folic acid), 1 g in during the breakfast (2 capsules) and the other 1 g (2 capsules) during the dinner.
Intervention Type
DIETARY_SUPPLEMENT
Other Intervention Names
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Intervened
Group A
Placebo
Group B
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of Type 2 Diabetes mellitus.
* Treated only with Metformin as unique treatment for diabetes.
* Treated only with Metformin as unique treatment for diabetes.
Exclusion Criteria
* Hypersensitivity or allergy reported to Cinnamomum spp. or Peruvian balm.
* Ulcer of gastrointestinal location.
* Chronic treatment with analgesics, antibiotics, estrogens, antineoplastics, antihypertensives of the beta-blocker type, anti-inflammatory, medications whose route of action is Gamma-Aminobutyric Acid and / or anticoagulants.
* Under treatment with steroid and / or aspirin.
* Subject that use alternative medicine treatments.
* Women of childbearing age who do not use any contraceptive method.
* Subjects subjected to surgical procedures in the 6 weeks prior to the beginning of the study.
* Subjects who presented fasting glycemia levels greater than 400 mg/dL in the previous control.
* Allergies to wheat and/or diagnosed with celiac disease.
* Adverse Drug Reaction during the study.
* Subjects whose treatment schedule changed during the study intervention.
* Subjects that does not accept to be part of the study, decides to leave the study or does not have adherence to the treatment provided.
* Ulcer of gastrointestinal location.
* Chronic treatment with analgesics, antibiotics, estrogens, antineoplastics, antihypertensives of the beta-blocker type, anti-inflammatory, medications whose route of action is Gamma-Aminobutyric Acid and / or anticoagulants.
* Under treatment with steroid and / or aspirin.
* Subject that use alternative medicine treatments.
* Women of childbearing age who do not use any contraceptive method.
* Subjects subjected to surgical procedures in the 6 weeks prior to the beginning of the study.
* Subjects who presented fasting glycemia levels greater than 400 mg/dL in the previous control.
* Allergies to wheat and/or diagnosed with celiac disease.
* Adverse Drug Reaction during the study.
* Subjects whose treatment schedule changed during the study intervention.
* Subjects that does not accept to be part of the study, decides to leave the study or does not have adherence to the treatment provided.
Minimum Eligible Age
40 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital Nacional Rosales
OTHER
Sponsor Role
collaborator
Unidad Comunitaria de Salud Familiar Intermedia de Comasagua (UCSFI-Comasagua)
UNKNOWN
Sponsor Role
collaborator
Asociación Salvadoreña de Diabetes (ASADI)
UNKNOWN
Sponsor Role
collaborator
Universidad Dr. José Matías Delgado
OTHER
Sponsor Role
lead
Responsible Party
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Miguel Antonio Padilla Pimentel, MD
Doctor of Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Miguel A Padilla, M.D.
Role: PRINCIPAL_INVESTIGATOR
Universidad Dr. José Matías Delgado
Ana E Centeno, M.D.
Role: PRINCIPAL_INVESTIGATOR
Universidad Dr. José Matías Delgado
Melissa V Abarca, M.D.
Role: PRINCIPAL_INVESTIGATOR
Universidad Dr. José Matías Delgado
Roberto W Cerritos, M.D.
Role: STUDY_CHAIR
Universidad de El Salvador, Hospital Nacional Rosales
William A Hoyos, M.D.
Role: PRINCIPAL_INVESTIGATOR
Universidad Dr. José Matías Delgado
Karla M Navarrete, M.D., MPh.
Role: PRINCIPAL_INVESTIGATOR
Secretaría Antidrogas de la Ciudad de San Salvador
Locations
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Unidad Comunitaria de Salud Familiar Intermedia de Comasagua (UCSFI-Comasagua)
Comasagua, La Libertad Department, El Salvador
Site Status
Countries
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El Salvador
References
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RESULT
Zare R, Nadjarzadeh A, Zarshenas MM, Shams M, Heydari M. Efficacy of cinnamon in patients with type II diabetes mellitus: A randomized controlled clinical trial. Clin Nutr. 2019 Apr;38(2):549-556. doi: 10.1016/j.clnu.2018.03.003. Epub 2018 Mar 11.
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Reference Type
RESULT
Feller S, Boeing H, Pischon T. Body mass index, waist circumference, and the risk of type 2 diabetes mellitus: implications for routine clinical practice. Dtsch Arztebl Int. 2010 Jul;107(26):470-6. doi: 10.3238/arztebl.2010.0470. Epub 2010 Jul 2.
Reference Type
RESULT
Funnell MM, Brown TL, Childs BP, Haas LB, Hosey GM, Jensen B, Maryniuk M, Peyrot M, Piette JD, Reader D, Siminerio LM, Weinger K, Weiss MA. National standards for diabetes self-management education. Diabetes Care. 2010 Jan;33 Suppl 1(Suppl 1):S89-96. doi: 10.2337/dc10-S089. No abstract available.
Reference Type
RESULT
Related Links
Access external resources that provide additional context or updates about the study.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.20.77
FDA - Substances Generally Recognized as Safe, Cinnamon bark, Ceylon.
https://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074468.htm
FDA - Compliance Policy Guides (CPGs), CPG Sec. 525.750 Spices - Definitions, 10. Cinnamon
http://www.diabetesatlas.org/
Diabetes Atlas, International Federation of Diabetes
http://apps.who.int/iris/bitstream/10665/254649/1/9789243565255-spa.pdf
World Health Organization. World report on diabetes 2016
Other Identifiers
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07-2017
Identifier Type: -
Identifier Source: org_study_id