Effect of Cinnamon on Glucose and Lipid Levels in Non-Ins... | NCT00237640

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

NCT00237640

Sponsor

University of Oklahoma

Status

Completed

Last Update Posted

Sep 22, 2008Estimated

Enrollment

85Actual

Phase

Phase 2

Conditions

Diabetes Mellitus, Adult Onset

Interventions

Cinnamon or placebo 500 mg capsule twice daily

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Oct 10, 2005

First Submission Date that Met QC Criteria

Oct 10, 2005

First Posted Date

Oct 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2008

Last Update Posted Date

Sep 22, 2008Estimated

Name	Class
National Center for Research Resources (NCRR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Drug: Cinnamon or placebo 500 mg capsule twice daily
2	Active Comparator		Drug: Cinnamon or placebo 500 mg capsule twice daily

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cinnamon or placebo 500 mg capsule twice daily	Drug	Cinnamon 500 mg capsule twice daily or placebo capsule twice daily	1 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steve M Blevins, M.D.	University of Oklahoma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Clinical Research Center		Oklahoma City	Oklahoma	73117	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17563345	Derived	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. doi: 10.2337/dc07-0098. Epub 2007 Jun 11. No abstract available.

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus
D006949	Hyperlipidemias
D007333	Insulin Resistance

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases