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

Type 2 Diabetes Mellitus Clinical Trial

— GCIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711682
• Other study ID #: 07-2017
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 1, 2018
• Est. completion date: May 23, 2018

Study information

• Verified date: November 2020
• Source: Universidad Dr. José Matías Delgado
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 23, 2018
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• 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.
• 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.

Locations

Country	Name	City	State
El Salvador	Unidad Comunitaria de Salud Familiar Intermedia de Comasagua (UCSFI-Comasagua)	Comasagua	La Libertad

Sponsors (4)

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

Country where clinical trial is conducted

El Salvador, 

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* Note: There are 61 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Theoretical HbA1c	Theoretical 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	Week 0, 4, 8, 12
Primary	Change in HbA1c		Week 0 and 12
Secondary	Change in Capillary Glucose		Week 0, 2, 4, 6, 8, 10, 12
Secondary	Change in Body Mass Index (BMI)		Week 0, 2, 4, 6, 8, 10, 12
Secondary	Change in Waist Circumference		Week 0, 2, 4, 6, 8, 10, 12
Secondary	Change in Diastolic pressure		Week 0, 2, 4, 6, 8, 10, 12
Secondary	Change in Systolic Pressure		Week 0, 2, 4, 6, 8, 10, 12

External Links

•   Diabetes Atlas, International Federation of Diabetes
•   Estimates and Projections of National Population 2005-2050, Departmental 2005-2025. El Salvador.
•   FDA - Compliance Policy Guides (CPGs), CPG Sec. 525.750 Spices - Definitions, 10. Cinnamon
•   FDA - Substances Generally Recognized as Safe, Cinnamon bark, Ceylon.
•   II Latin American Consensus on Obesity. Latin American Federation of Obesity Societies
•   National Survey of chronic noncommunicable diseases in the adult population of El Salvador.
•   Work report 2015-2016. Ministry of Health of El Salvador.
•   World Health Organization. Country profiles for diabetes 2016, El Salvador.
•   World Health Organization. World report on diabetes 2016