Reducing Plasma Glucose Effect of Cinnamon in Type 2 Diabetic Patients in the Municipality of Comasagua
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Cinnamon; Wheat Flour
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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 intervention name(s): Intervened; Group A; Placebo; Group B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
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