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Reducing Plasma Glucose Effect of Cinnamon in Type 2 Diabetic Patients in the Municipality of Comasagua

Hypoglycemic Effect of Cinnamomum Verum in Type 2 Diabetic Patients in the Municipality of Comasagua

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03711682
Acronym
GCIG
Enrollment
30
Registered
2018-10-18
Start date
2018-03-01
Completion date
2018-05-23
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DIETARY_SUPPLEMENTCinnamon

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.

DIETARY_SUPPLEMENTWheat 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.

Sponsors

Hospital Nacional Rosales
CollaboratorOTHER
Unidad Comunitaria de Salud Familiar Intermedia de Comasagua (UCSFI-Comasagua)
CollaboratorUNKNOWN
Asociación Salvadoreña de Diabetes (ASADI)
CollaboratorUNKNOWN
Universidad Dr. José Matías Delgado
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in HbA1cWeek 0 and 12

Secondary

MeasureTime frame
Change in Capillary GlucoseWeek 0, 2, 4, 6, 8, 10, 12
Change in Body Mass Index (BMI)Week 0, 2, 4, 6, 8, 10, 12
Change in Diastolic pressureWeek 0, 2, 4, 6, 8, 10, 12
Change in Systolic PressureWeek 0, 2, 4, 6, 8, 10, 12
Change in Waist CircumferenceWeek 0, 2, 4, 6, 8, 10, 12

Other

MeasureTime frameDescription
Change in Theoretical HbA1cWeek 0, 4, 8, 12Theoretical HbA1c, calculated using the mean of the capillary glucose of each month (every 4 weeks), and the formula A1c% = (AG mg/dL + 46.7) / 28.7

Countries

El Salvador

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026