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Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin for Treatment of Type 2 DM.

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Mike O'Callaghan Federal Hospital
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01302743
First received: February 17, 2011
Last updated: August 1, 2016
Last verified: August 2016

February 17, 2011
August 1, 2016
November 2010
April 2017   (final data collection date for primary outcome measure)
Determine which form of cinnamon is better at lowering HbA1c, LDL cholesterol & waist circumference [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Subjects will have baseline blood levels to measure HbA1c and lipid panel. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.
Determine which form of cinnamon is better at lowering HbA1c, LDL cholesterol & waist circumference [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Subjects will have baseline blood levels to measure HbA1c and lipid panel. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levles of HbA1c and lipid panel will be drawn again.
Complete list of historical versions of study NCT01302743 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin for Treatment of Type 2 DM.
Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus: A Randomized, Controlled Trial.
The purpose of this study is to assess whether Cinnamon bark or water-soluble cinnamon is an effective nutraceutical for the initial treatment of diabetes when compared to standard therapy of Metformin.
We are studying whether or not cinnamon bark or water-soluble cinnamon could be an effective nutraceutical for the initial treatment of diabetes when compared to standard therapy of metformin 1000 mg (extended-release). This study will enroll 309 subjects type 2 diabetics (using American Diabetes Association criteria) on no hypoglycemic medications. Subjects will be randomized into one of three groups, group 1 will receive oral extended-release Metformin 1000mg, group 2 will receive Cinnamon Bark 1000mg, group 3 will receive cinnulin PF 500mg. Subjects will be instructed to take their study pills once a day for 90 days.After 90 days of treatment, each subject will again have hemoglobin A1C, lipid panel, height, weight, blood pressure and waist circumference measured. Analysis described above using intention-to-treat principles for any missing data will be used (we will use the carry-forward method to impute missing data). Subjects will bring in any remaining medication to determine adherence rates to the study protocol.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes
  • Drug: Group 1: Metformin
    Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days
  • Dietary Supplement: Group 2: Cinnamon Bark
    Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days
  • Dietary Supplement: Group 3: Cinnulin PF
    Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.
  • Active Comparator: Metformin
    Will receive oral extended-release Metformin 1000 mg once a day for 90 days
    Intervention: Drug: Group 1: Metformin
  • Experimental: Cinnamon Bark
    Will receive Cinnamon Bark 1000 mg once a day for 90 days
    Intervention: Dietary Supplement: Group 2: Cinnamon Bark
  • Experimental: Cinnulin PF
    Will receive Cinnulin PF 500 mg once a day for 90 days
    Intervention: Dietary Supplement: Group 3: Cinnulin PF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
309
April 2017
April 2017   (final data collection date for primary outcome measure)

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion:

  • Patients 18 years or older.
  • Diagnosed with type 2 diabetes mellitus within the past 30 days or who have been diagnosed and have not begun treatment.

Exclusion:

  • Subjects who are <18 yrs of age.
  • Pregnant or breastfeeding.
  • Allergic to cinnamon.
  • Allergic to metformin.
  • Patients taking metformin are excluded from participating, unless they agree to wash out for two weeks prior to entering the study.
  • Patients taking Cinnamon as a dietary supplement are excluded from participating, unless they agree to wash out for two weeks prior to entering the study.
  • Patients taking any of the following:

    • Daily oral steroids
    • Warfarin
    • Hypoglycemic medication
    • Weight loss medication
    • Digoxin, lithium, phenytoin, & theophylline (due to narrow therapeutic indices)
  • Serum creatinine >1.5 (this is standard of care that would be measured by PCM upon diagnosis of type 2 diabetes mellitus)
  • Initial hemoglobin A1C >9.5(this is standard of care that would be measured by PCM upon diagnosis of type 2 diabetes mellitus).
  • Clinical or laboratory evidence of liver disease.
  • Clinical or laboratory evidence of Alcoholism.
  • New York Heart Association (NYHA) Class III and IV congestive heart failure.

    • Class III: Cardiac disease resulting in marked limitation of physical activity - less than ordinary activity causes fatigue, palpitation, dyspnea, or angina. Comfortable at rest.
    • Class IV: Cardiac disease resulting in inability to carry on any physical activity without discomfort or symptoms. Symptoms may be present at rest. If any physical activity is undertaken, discomfort or symptoms are increased.
  • Patients who are known to have or develop during the study any of the following upon review of their medical record:

    • Celiac disease
    • Insulinoma
    • Cushings Disease
    • Hyperthyroidism
    • Acromegaly
    • Phechromocytoma
    • Addison's Disease
    • Galactosemia
    • Glycogen storage disease
    • Hereditary fructose intolerance
Both
18 Years and older   (Adult, Senior)
No
Contact: Jill M Clark, MBA/HCM 7026533298 jill.clark.3.ctr@us.af.mil
Contact: Paul Crawford, M.D. 7026533298 paul.crawford@us.af.mil
United States
 
NCT01302743
FWH20110004H
No
No
Not Provided
Mike O'Callaghan Federal Hospital
Mike O'Callaghan Federal Hospital
Not Provided
Principal Investigator: Paul Crawford, M.D. Mike O'Callaghan Federal Hospital/Nellis Air Force Base
Mike O'Callaghan Federal Hospital
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP