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

This study has been terminated.
(lack of recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302743
First Posted: February 24, 2011
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mike O'Callaghan Military Hospital
  Purpose
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.

Condition Intervention
Diabetes Drug: Group 1: Metformin Dietary Supplement: Group 2: Cinnamon Bark Dietary Supplement: Group 3: Cinnulin PF

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus: A Randomized, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Mike O'Callaghan Military Hospital:

Primary Outcome Measures:
  • Decrease in HbA1c [ Time Frame: 90 days ]
    Subjects will have baseline blood levels to measure HbA1c. 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.

  • Decrease in LDL Cholesterol [ Time Frame: 90 days ]
    Subjects will have baseline blood levels to measure LDL Cholesterol. 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.


Enrollment: 25
Study Start Date: November 2010
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin
oral extended-release Metformin 1000 mg once a day for 90 days
Drug: Group 1: Metformin
Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days
Experimental: Cinnamon Bark
Cinnamon Bark 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
Experimental: Cinnulin PF
Cinnulin PF 500 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.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302743


Locations
United States, Nevada
Mike O'Callaghan Federal Hospital
Nellis Air Force Base, Nevada, United States, 89191
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
Investigators
Principal Investigator: Paul Crawford, M.D. Mike O'Callaghan Federal Hospital/Nellis Air Force Base
  More Information

Responsible Party: Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT01302743     History of Changes
Other Study ID Numbers: FWH20110004H
First Submitted: February 17, 2011
First Posted: February 24, 2011
Results First Submitted: December 15, 2016
Results First Posted: March 28, 2017
Last Update Posted: June 26, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mike O'Callaghan Military Hospital:
Diabetes
Metformin
Cinnamon

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs