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

Primary Purpose

Diabetes

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group 1: Metformin
Group 2: Cinnamon Bark
Group 3: Cinnulin PF
Sponsored by
Mike O'Callaghan Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetes, Metformin, Cinnamon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mike O'Callaghan Federal Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Metformin

Cinnamon Bark

Cinnulin PF

Arm Description

oral extended-release Metformin 1000 mg once a day for 90 days

Cinnamon Bark 1000 mg once a day for 90 days

Cinnulin PF 500 mg once a day for 90 days

Outcomes

Primary Outcome Measures

Decrease in HbA1c
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
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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2011
Last Updated
May 31, 2017
Sponsor
Mike O'Callaghan Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01302743
Brief Title
Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin for Treatment of Type 2 DM.
Official Title
Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus: A Randomized, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mike O'Callaghan Military Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Diabetes, Metformin, Cinnamon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
oral extended-release Metformin 1000 mg once a day for 90 days
Arm Title
Cinnamon Bark
Arm Type
Experimental
Arm Description
Cinnamon Bark 1000 mg once a day for 90 days
Arm Title
Cinnulin PF
Arm Type
Experimental
Arm Description
Cinnulin PF 500 mg once a day for 90 days
Intervention Type
Drug
Intervention Name(s)
Group 1: Metformin
Intervention Description
Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Group 2: Cinnamon Bark
Intervention Description
Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Group 3: Cinnulin PF
Intervention Description
Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.
Primary Outcome Measure Information:
Title
Decrease in HbA1c
Description
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.
Time Frame
90 days
Title
Decrease in LDL Cholesterol
Description
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Crawford, M.D.
Organizational Affiliation
Mike O'Callaghan Federal Hospital/Nellis Air Force Base
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mike O'Callaghan Federal Hospital
City
Nellis Air Force Base
State/Province
Nevada
ZIP/Postal Code
89191
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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