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

November 5, 2020 updated by: Miguel Antonio Padilla Pimentel, MD, Universidad Dr. José Matías Delgado

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • El Salvador
    • La Libertad
      • Comasagua, La Libertad, El Salvador, 0504
        • Unidad Comunitaria de Salud Familiar Intermedia de Comasagua (UCSFI-Comasagua)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cinnamon (Intervented)
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.
Other Names:
  • Group A
  • Intervened
Placebo Comparator: Wheat Flour (Placebo)
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.
Other Names:
  • Placebo
  • Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: Week 0 and 12
Week 0 and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Capillary Glucose
Time Frame: Week 0, 2, 4, 6, 8, 10, 12
Week 0, 2, 4, 6, 8, 10, 12
Change in Body Mass Index (BMI)
Time Frame: Week 0, 2, 4, 6, 8, 10, 12
Week 0, 2, 4, 6, 8, 10, 12
Change in Waist Circumference
Time Frame: Week 0, 2, 4, 6, 8, 10, 12
Week 0, 2, 4, 6, 8, 10, 12
Change in Diastolic pressure
Time Frame: Week 0, 2, 4, 6, 8, 10, 12
Week 0, 2, 4, 6, 8, 10, 12
Change in Systolic Pressure
Time Frame: Week 0, 2, 4, 6, 8, 10, 12
Week 0, 2, 4, 6, 8, 10, 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Theoretical HbA1c
Time Frame: Week 0, 4, 8, 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Dr. José Matías Delgado

Collaborators

Hospital Nacional Rosales
Unidad Comunitaria de Salud Familiar Intermedia de Comasagua (UCSFI-Comasagua)
Asociación Salvadoreña de Diabetes (ASADI)

Investigators

  • Principal Investigator: Miguel A Padilla, M.D., Universidad Dr. José Matías Delgado
  • Principal Investigator: Ana E Centeno, M.D., Universidad Dr. José Matías Delgado
  • Principal Investigator: Melissa V Abarca, M.D., Universidad Dr. José Matías Delgado
  • Study Chair: Roberto W Cerritos, M.D., Universidad de El Salvador, Hospital Nacional Rosales
  • Principal Investigator: William A Hoyos, M.D., Universidad Dr. José Matías Delgado
  • Principal Investigator: Karla M Navarrete, M.D., MPh., Secretaría Antidrogas de la Ciudad de San Salvador

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

May 23, 2018

Study Completion (Actual)

May 23, 2018

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There's not Individual Patient Data sharing plan because at the moment the participants signed the informed consent it stipulate their individual data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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