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

Diabetes Mellitus, Adult Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237640
• Other study ID #: 11798
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2005
• Last updated: September 19, 2008
• Start date: March 2005
• Est. completion date: July 2007

Study information

• Verified date: September 2008
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Adult Onset
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Cinnamon or placebo 500 mg capsule twice daily
Cinnamon 500 mg capsule twice daily or placebo capsule twice daily

Locations

Country	Name	City	State
United States	General Clinical Research Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels.		3 months

External Links

•   General Clinical Research Center --- Home Page