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

May 31, 2017 updated by: Mike O'Callaghan Military Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Nellis Air Force Base, Nevada, United States, 89191
        • Mike O'Callaghan Federal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mike O'Callaghan Military Hospital

Investigators

  • Principal Investigator: Paul Crawford, M.D., Mike O'Callaghan Federal Hospital/Nellis Air Force Base

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20110004H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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