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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00237640
First received: October 10, 2005
Last updated: September 19, 2008
Last verified: September 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00237640

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

No publications provided by University of Oklahoma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00237640     History of Changes
Other Study ID Numbers: 11798
Study First Received: October 10, 2005
Last Updated: September 19, 2008
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 26, 2014