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Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00237640
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : September 22, 2008
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
University of Oklahoma

Tracking Information
First Submitted Date  ICMJE October 10, 2005
First Posted Date  ICMJE October 12, 2005
Last Update Posted Date September 22, 2008
Study Start Date  ICMJE March 2005
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2007)
- Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels. [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2005)
- Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels.
Change History Complete list of historical versions of study NCT00237640 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus
Official Title  ICMJE Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus
Brief Summary The purpose of this study is to determine the effects of cinnamon on serum glucose and lipid levels in people with non-insulin dependent type 2 diabetes mellitus.
Detailed Description Forty people with non-insulin dependent type 2 diabetes mellitus will be randomized to receive either cinnamon or placebo for three months. The dose of cinnamon will be one gram daily. Fasting serum glucose, triglyceride, total cholesterol, LDL, HDL, and insulin levels will be measured at baseline and at 1, 2, and 3 months. HbA1c levels will be measured at baseline and at 3 months. Patients will be monitored for compliance, adverse effects, and dietary changes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Adult Onset
Intervention  ICMJE Drug: Cinnamon or placebo 500 mg capsule twice daily
Cinnamon 500 mg capsule twice daily or placebo capsule twice daily
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: Cinnamon or placebo 500 mg capsule twice daily
  • Active Comparator: 2
    Intervention: Drug: Cinnamon or placebo 500 mg capsule twice daily
Publications * Blevins SM, Leyva MJ, Brown J, Wright J, Scofield RH, Aston CE. Effect of cinnamon on glucose and lipid levels in non insulin-dependent type 2 diabetes. Diabetes Care. 2007 Sep;30(9):2236-7. Epub 2007 Jun 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2007)
85
Original Enrollment  ICMJE
 (submitted: October 10, 2005)
40
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • HbA1C > 6.0%
  • Age 18 and above
  • Able to obtain consent

Exclusion Criteria:

  • Currently taking insulin
  • Pregnancy
  • End-stage renal disease
  • Hemolytic anemia
  • Cinnamon intolerance
  • Inability or unwillingness to adhere to study protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00237640
Other Study ID Numbers  ICMJE 11798
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Steve M Blevins, M.D. University of Oklahoma
PRS Account University of Oklahoma
Verification Date September 2008

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