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

• Sponsor: University of Oklahoma (Other)
• Overall Status: Completed
• CT.gov ID: NCT00237640
• Collaborator: National Center for Research Resources (NCRR) (NIH)
• Enrollment: 85
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• 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
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. - Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels. [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00237640
• Other Study ID Numbers: 11798
• First Posted: Oct 12, 2005
• Last Update Posted: Sep 22, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: Cinnamon; Diabetes mellitus; Hyperlipidemia; Insulin Resistance
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 22, 2008