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

Sponsors and Collaborators:	University of Oklahoma National Center for Research Resources (NCRR)
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00237640

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 II

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Dextrose Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus

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
1: Placebo Comparator	Drug: Cinnamon or placebo 500 mg capsule twice daily Cinnamon 500 mg capsule twice daily or placebo capsule twice daily
2: Active Comparator	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

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

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:

Steve M Blevins, M.D.

University of Oklahoma

More Information

General Clinical Research Center --- Home Page This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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. No abstract available.

Study ID Numbers:	11798
Study First Received:	October 10, 2005
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00237640
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

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 16, 2009