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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00237640
First Posted: October 12, 2005
Last Update Posted: September 22, 2008
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.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
University of Oklahoma
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus, Adult Onset Drug: Cinnamon or placebo 500 mg capsule twice daily Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • - Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels. [ Time Frame: 3 months ]

Enrollment: 85
Study Start Date: March 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Cinnamon or placebo 500 mg capsule twice daily
Cinnamon 500 mg capsule twice daily or placebo capsule twice daily
Active Comparator: 2 Drug: Cinnamon or placebo 500 mg capsule twice daily
Cinnamon 500 mg capsule twice daily or placebo capsule twice daily

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237640


Locations
United States, Oklahoma
General Clinical Research Center
Oklahoma City, Oklahoma, United States, 73117
Sponsors and Collaborators
University of Oklahoma
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Steve M Blevins, M.D. University of Oklahoma
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00237640     History of Changes
Other Study ID Numbers: 11798
First Submitted: October 10, 2005
First Posted: October 12, 2005
Last Update Posted: September 22, 2008
Last Verified: September 2008

Keywords provided by University of Oklahoma:
Cinnamon
Diabetes mellitus
Hyperlipidemia
Insulin Resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases