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Randomized Controlled Clinical Trial of Cinnamon to Lower Hemoglobin A1c
This study is currently recruiting participants.
Verified by Eglin AFB Regional Hospital, March 2007
Sponsored by: Eglin AFB Regional Hospital
Information provided by: Eglin AFB Regional Hospital
ClinicalTrials.gov Identifier: NCT00445354
  Purpose

This study will randomize diabetics with hemoglobin A1c greater than 7.0 to receive either cinnamon plus usual care or usual care alone. Hemoglobin A1c will be measured at intake and after 90 days.


Condition Intervention Phase
Diabetes
Drug: cinnamon
Phase III

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized Controlled Clinical Trial Comparing the Effect of 1g of Daily Cinnamon Plus Usual Care to Usual Cre on the Hemoglobin A1c of Uncontrolled Type 2 Diabetics

Further study details as provided by Eglin AFB Regional Hospital:

Primary Outcome Measures:
  • hemoglobin A1c

Secondary Outcome Measures:
  • diabetes medications

Estimated Enrollment: 140
Study Start Date: March 2007
Estimated Study Completion Date: August 2007
Detailed Description:

As the worldwide incidence of diabetes increases, the search for dietary adjuncts to treat this life-altering disease becomes far ranging. Cinnamon is purported to be a natural insulin sensitizer without any known adverse events. Both in vitro and in vivo animal studies have shown that cinnamon is an insulin sensitizer1. Several compounds within cinnamon have been identified as possible sources of this sensitization process.

To-date, three small randomized trials studying cinnamon in human diabetics have been published. Khan et al. reported that fasting serum glucose could be reduced by 18-29% after 40 days of supplementation with 1, 3, or 6 g of cinnamon (Cinnamomum cassia) in type 2 diabetics. 2 This study had several limitations that included failure to measure hemoglobin A1C, all patients were Pakistani, and no power analysis was documented. Vanschoonbeek, et al.3 report a small RCT of postmenopausal women with well-controlled type 2 diabetes which showed no change in HbA1C or fasting glucose. Once again no power analysis is reported. Mang et al. 4 conducted a RCT of type 2 diabetics treated with aqueous extract of cinnamon for 4 months. They report a 15% decrease in fasting glucose and no change in HbA1C over the duration of this trial. Subjects had HbA1C less than 7% and again no power analysis was included in this study.

This study will address whether cinnamon at the dose of 1g daily in addition to usual care lowers hemoglobin A1c compared to usual care. Power analysis indicates that 63 per group are needed and we will recruit 70 patients.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 diabetics greater tahn 18 years of age

Exclusion Criteria:

  • allergy to cinnamon pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445354

Contacts
Contact: Paul Crawford, MD 850-883-8879 paul.crawford2@eglin.af.mil

Locations
United States, Florida
Eglin AFB Regional Hospital Recruiting
Eglin AFB, Florida, United States, 32542
Contact: James Whitworth, PhD     850-883-8288     james.whitworth@eglin.af.mil    
Principal Investigator: Paul F Crawford, MD            
Sub-Investigator: Karen L Weis, PhD            
Sponsors and Collaborators
Eglin AFB Regional Hospital
Investigators
Principal Investigator: Paul F Crawford, MD Eglin AFB Hospital
  More Information

Publications:
Study ID Numbers: FWH20060194H
Study First Received: March 7, 2007
Last Updated: March 7, 2007
ClinicalTrials.gov Identifier: NCT00445354  
Health Authority: United States: Federal Government

Keywords provided by Eglin AFB Regional Hospital:
cinnamon
diabetes
hemoglobin a1c

Study placed in the following topic categories:
Diabetes Mellitus

ClinicalTrials.gov processed this record on January 16, 2009