Clinical trial NCT03711682: Reducing Plasma Glucose Effect of Cinnamon in Type 2 Diabetic Patients in the Municipality of Comasagua
Official title: Hypoglycemic Effect of Cinnamomum Verum in Type 2 Diabetic Patients in the Municipality of Comasagua
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: 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
Lead sponsor: Universidad Dr. José Matías Delgado
Sponsor class: OTHER
Collaborators: name: Hospital Nacional Rosales
name: Unidad Comunitaria de Salud Familiar Intermedia de Comasagua (UCSFI-Comasagua)
name: Asociación Salvadoreña de Diabetes (ASADI)
First posted: 2018-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Type 2 Diabetes mellitus.
* 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: Week 0 and 12
Secondary outcomes:
measure: Change in Capillary Glucose
timeFrame: Week 0, 2, 4, 6, 8, 10, 12
measure: Change in Body Mass Index (BMI)
timeFrame: Week 0, 2, 4, 6, 8, 10, 12
measure: Change in Waist Circumference
timeFrame: Week 0, 2, 4, 6, 8, 10, 12
measure: Change in Diastolic pressure
timeFrame: Week 0, 2, 4, 6, 8, 10, 12
measure: Change in Systolic Pressure
timeFrame: Week 0, 2, 4, 6, 8, 10, 12
Other outcomes:
measure: Change in Theoretical HbA1c
timeFrame: Week 0, 4, 8, 12
Locations:
city: Comasagua
country: El Salvador
facility: Unidad Comunitaria de Salud Familiar Intermedia de Comasagua (UCSFI-Comasagua)
state: La Libertad
Study officials:
affiliation: Universidad Dr. José Matías Delgado
name: Miguel A Padilla, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Dr. José Matías Delgado
name: Ana E Centeno, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Dr. José Matías Delgado
name: Melissa V Abarca, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de El Salvador, Hospital Nacional Rosales
name: Roberto W Cerritos, M.D.
role: STUDY_CHAIR
affiliation: Universidad Dr. José Matías Delgado
name: William A Hoyos, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Secretaría Antidrogas de la Ciudad de San Salvador
name: Karla M Navarrete, M.D., MPh.
role: PRINCIPAL_INVESTIGATOR
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