Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus: A Randomized, Controlled Trial.

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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: October 10, 2014
Last verified: October 2014

February 17, 2011
October 10, 2014
November 2010
April 2016   (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
Not Provided
Not Provided
 
Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus: A Randomized, Controlled Trial.
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.

Not Provided
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 2016
April 2016   (final data collection date for primary outcome measure)

Inclusion:

• Patients over the age of 18 with newly diagnosed type 2 diabetes mellitus within the last month.

Exclusion:

  • Subjects who are <18 yrs of age.
  • Pregnant or breastfeeding.
  • Allergic to cinnamon or metformin.
  • Already taking metformin, cinnamon, or other hypoglycemic medication.
  • Taking warfarin.
  • Serum creatinine >1.5 (this is standard of care that would be measured by PCM upon diagnosis of type 2 diabetes mellitus)
  • Initial hemoglobin >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.
Both
18 Years and older
No
Contact: Jill M Clark, MBA/HCM, CCRP, CCRC 7026533298 jill.clark.3.ctr@us.af.mil
Contact: Paul Crawford, M.D. 7026533298 paul.crawford@us.af.mil
United States
 
NCT01302743
FWH20110004H
No
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
October 2014

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