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Type 2 Diabetes MellitusPhase 2/3GCIGNCT03711682

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

A Phase 2/3 study testing Cinnamon and Wheat Flour in people with Type 2 Diabetes Mellitus, run by Universidad Dr. José Matías Delgado at 1 site in El Salvador.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Cinnamon and Wheat Flour
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteEl Salvador
Study dates
1 Mar 2018to 23 May 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of Type 2 Diabetes mellitus.
  • Treated only with Metformin as unique treatment for diabetes.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

El Salvador1 site

  • Unidad Comunitaria de Salud Familiar Intermedia de Comasagua (UCSFI-Comasagua)

    Comasagua, La Libertad Department, 0504

Other trials in El Salvador

About this study

Official title: 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.

Read the 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.

Being tested
Cinnamon, Wheat Flour
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
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CinnamonDietary supplement

    Also called Intervened, Group A

    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 FlourDietary supplement

    Also called Placebo, Group B

    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.

Study groups in NCT03711682
Study groupRoleWhat they receive
Cinnamon (Intervented)ExperimentalNot described
Receives: Dietary Supplement: Cinnamon
Wheat Flour (Placebo)Placebo comparatorNot described
Receives: Dietary Supplement: Wheat Flour

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Measured: Week 0 and 12

Secondary outcomes (5)

  1. Change in Capillary Glucose

    Measured: Week 0, 2, 4, 6, 8, 10, 12

  2. Change in Body Mass Index (BMI)

    Measured: Week 0, 2, 4, 6, 8, 10, 12

  3. Change in Waist Circumference

    Measured: Week 0, 2, 4, 6, 8, 10, 12

  4. Change in Diastolic pressure

    Measured: Week 0, 2, 4, 6, 8, 10, 12

  5. Change in Systolic Pressure

    Measured: Week 0, 2, 4, 6, 8, 10, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2018
  2. Study start1 Mar 2018
  3. Primary completion23 May 2018
  4. Study completion23 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03711682
Sponsor's protocol ID
07-2017
Acronym
GCIG
Status last verified
Nov 2020
First submitted
16 Oct 2018
Last updated
9 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Medagama AB. The glycaemic outcomes of Cinnamon, a review of the experimental evidence and clinical trials. Nutr J. 2015 Oct 16;14:108. doi: 10.1186/s12937-015-0098-9.

    PubMed 26475130

  • Cramer JA. A systematic review of adherence with medications for diabetes. Diabetes Care. 2004 May;27(5):1218-24. doi: 10.2337/diacare.27.5.1218.

    PubMed 15111553

  • American Diabetes Association; Bantle JP, Wylie-Rosett J, Albright AL, Apovian CM, Clark NG, Franz MJ, Hoogwerf BJ, Lichtenstein AH, Mayer-Davis E, Mooradian AD, Wheeler ML. Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2008 Jan;31 Suppl 1:S61-78. doi: 10.2337/dc08-S061. No abstract available.

    PubMed 18165339

  • Yeh GY, Eisenberg DM, Kaptchuk TJ, Phillips RS. Systematic review of herbs and dietary supplements for glycemic control in diabetes. Diabetes Care. 2003 Apr;26(4):1277-94. doi: 10.2337/diacare.26.4.1277.

    PubMed 12663610

  • American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. No abstract available.

    PubMed 25537714

  • Ros Perez M, Medina-Gomez G. [Obesity, adipogenesis and insulin resistance]. Endocrinol Nutr. 2011 Aug-Sep;58(7):360-9. doi: 10.1016/j.endonu.2011.05.008. Epub 2011 Jul 22. Spanish.

    PubMed 21778123

  • Canivell S, Gomis R. Diagnosis and classification of autoimmune diabetes mellitus. Autoimmun Rev. 2014 Apr-May;13(4-5):403-7. doi: 10.1016/j.autrev.2014.01.020. Epub 2014 Jan 11.

    PubMed 24424179

  • Unoki H, Takahashi A, Kawaguchi T, Hara K, Horikoshi M, Andersen G, Ng DP, Holmkvist J, Borch-Johnsen K, Jorgensen T, Sandbaek A, Lauritzen T, Hansen T, Nurbaya S, Tsunoda T, Kubo M, Babazono T, Hirose H, Hayashi M, Iwamoto Y, Kashiwagi A, Kaku K, Kawamori R, Tai ES, Pedersen O, Kamatani N, Kadowaki T, Kikkawa R, Nakamura Y, Maeda S. SNPs in KCNQ1 are associated with susceptibility to type 2 diabetes in East Asian and European populations. Nat Genet. 2008 Sep;40(9):1098-102. doi: 10.1038/ng.208.

    PubMed 18711366

  • Chen L, Magliano DJ, Zimmet PZ. The worldwide epidemiology of type 2 diabetes mellitus--present and future perspectives. Nat Rev Endocrinol. 2011 Nov 8;8(4):228-36. doi: 10.1038/nrendo.2011.183.

    PubMed 22064493

  • Ye J. Mechanisms of insulin resistance in obesity. Front Med. 2013 Mar;7(1):14-24. doi: 10.1007/s11684-013-0262-6. Epub 2013 Mar 9.

    PubMed 23471659

  • Sacks DB. Measurement of hemoglobin A(1c): a new twist on the path to harmony. Diabetes Care. 2012 Dec;35(12):2674-80. doi: 10.2337/dc12-1348. No abstract available.

    PubMed 23173136

  • Sacks DB. Correlation between hemoglobin A1c (HbA1c) and average blood glucose: can HbA1c be reported as estimated blood glucose concentration? J Diabetes Sci Technol. 2007 Nov;1(6):801-3. doi: 10.1177/193229680700100602. No abstract available.

    PubMed 19885151

  • Unnikrishnan R, Anjana RM, Mohan V. Drugs affecting HbA1c levels. Indian J Endocrinol Metab. 2012 Jul;16(4):528-31. doi: 10.4103/2230-8210.98004.

    PubMed 22837911

  • Tancredi M, Rosengren A, Svensson AM, Kosiborod M, Pivodic A, Gudbjornsdottir S, Wedel H, Clements M, Dahlqvist S, Lind M. Excess Mortality among Persons with Type 2 Diabetes. N Engl J Med. 2015 Oct 29;373(18):1720-32. doi: 10.1056/NEJMoa1504347.

    PubMed 26510021

  • Guthrie RA, Guthrie DW. Pathophysiology of diabetes mellitus. Crit Care Nurs Q. 2004 Apr-Jun;27(2):113-25. doi: 10.1097/00002727-200404000-00003.

    PubMed 15137354

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cinnamon and Wheat Flour in people with Type 2 Diabetes Mellitus, run by Universidad Dr. José Matías Delgado at 1 site in El Salvador.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: Week 0 and 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03711682, which also lists 61 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.

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