Randomized Controlled Clinical Trial of Cinnamon to Lower Hemoglobin A1c

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Eglin AFB Regional Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eglin AFB Regional Hospital
ClinicalTrials.gov Identifier:
NCT00445354
First received: March 7, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00445354     History of Changes
Other Study ID Numbers: FWH20060194H
Study First Received: March 7, 2007
Last Updated: March 7, 2007
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 18, 2014