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

This study is not yet open for participant recruitment.
Verified April 2012 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: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to see whether or not cinnamon or water-soluble cinnamon extract 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 Blind (Subject, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 309
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
  • 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 or cinnamon or other hypoglycemic medication
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302743

Contacts
Contact: Jill M Teixeira, MBA/HCM, CCRP, CCRC 702653-2756 jill.teixeira@nellis.af.mil
Contact: Paul Crawford, M.D. 7026532756 paul.crawford@nellis.af.mil

Locations
United States, Nevada
Mike O'Callaghan Federal Hospital Not yet recruiting
Nellis AFB, Nevada, United States, 89191
Contact: Tracy Bogdanovich     7026532756     tracy.bogdanovich@nellis.af.mil    
Contact: Jill M Teixeira, MBA/HCM, CCRP, CCRC     7026532756     jill.teixeira@nellis.af.mil    
Principal Investigator: Paul Crawford, M.D.            
Sub-Investigator: Justin Crop, D.O.            
Sub-Investigator: Carlton Covey, M.D.            
Sponsors and Collaborators
Mike O'Callaghan Federal Hospital
Investigators
Principal Investigator: Paul Crawford, M.D. Mike O'Callaghan Federal Hospital/Nellis Air Force Base
  More Information

No publications provided

Responsible Party: Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier: NCT01302743     History of Changes
Other Study ID Numbers: FWH20110004H
Study First Received: February 17, 2011
Last Updated: April 19, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013