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 November 2013 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: November 21, 2013
Last verified: November 2013
  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 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:


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 levels of HbA1c and lipid panel will be drawn again.


Estimated Enrollment: 309
Study Start Date: November 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin
Will receive 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
Will receive 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
Will receive 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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302743

Contacts
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

Locations
United States, Nevada
Mike O'Callaghan Federal Hospital Recruiting
Nellis AFB, Nevada, United States, 89191
Contact: Jill Clark, MBA/HCM, CCRP, CCRC    7026533298    jill.clark.3.ctr@us.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: November 21, 2013
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 July 24, 2014