Clinical trial NCT01302743: Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin for Treatment of Type 2 DM.
Official title: Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus: A Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Metformin
Cinnamon
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2011-02-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether Cinnamon bark or water-soluble cinnamon is an effective nutraceutical for the initial treatment of diabetes when compared to standard therapy of Metformin.

Detailed description: We are studying whether or not cinnamon bark or water-soluble cinnamon could be an effective nutraceutical for the initial treatment of diabetes when compared to standard therapy of metformin 1000 mg (extended-release). This study will enroll 309 subjects type 2 diabetics (using American Diabetes Association criteria) on no hypoglycemic medications. Subjects will be randomized into one of three groups, group 1 will receive oral extended-release Metformin 1000mg, group 2 will receive Cinnamon Bark 1000mg, group 3 will receive cinnulin PF 500mg. Subjects will be instructed to take their study pills once a day for 90 days.After 90 days of treatment, each subject will again have hemoglobin A1C, lipid panel, height, weight, blood pressure and waist circumference measured. Analysis described above using intention-to-treat principles for any missing data will be used (we will use the carry-forward method to impute missing data). Subjects will bring in any remaining medication to determine adherence rates to the study protocol.

Eligibility criteria: THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion:

* Patients 18 years or older.
* Diagnosed with type 2 diabetes mellitus within the past 30 days or who have been diagnosed and have not begun treatment.

Exclusion:

* Subjects who are \<18 yrs of age.
* Pregnant or breastfeeding.
* Allergic to cinnamon.
* Allergic to metformin.
* Patients taking metformin are excluded from participating, unless they agree to wash out for two weeks prior to entering the study.
* Patients taking Cinnamon as a dietary supplement are excluded from participating, unless they agree to wash out for two weeks prior to entering the study.
* Patients taking any of the following:

  * Daily oral steroids
  * Warfarin
  * Hypoglycemic medication
  * Weight loss medication
  * Digoxin, lithium, phenytoin, \& theophylline (due to narrow therapeutic indices)
* Serum creatinine \>1.5 (this is standard of care that would be measured by PCM upon diagnosis of type 2 diabetes mellitus)
* Initial hemoglobin A1C \>9.5(this is standard of care that would be measured by PCM upon diagnosis of type 2 diabetes mellitus).
* Clinical or laboratory evidence of liver disease.
* Clinical or laboratory evidence of Alcoholism.
* New York Heart Association (NYHA) Class III and IV congestive heart failure.

  * Class III: Cardiac disease resulting in marked limitation of physical activity - less than ordinary activity causes fatigue, palpitation, dyspnea, or angina. Comfortable at rest.
  * Class IV: Cardiac disease resulting in inability to carry on any physical activity without discomfort or symptoms. Symptoms may be present at rest. If any physical activity is undertaken, discomfort or symptoms are increased.
* Patients who are known to have or develop during the study any of the following upon review of their medical record:

  * Celiac disease
  * Insulinoma
  * Cushings Disease
  * Hyperthyroidism
  * Acromegaly
  * Phechromocytoma
  * Addison's Disease
  * Galactosemia
  * Glycogen storage disease
  * Hereditary fructose intolerance

Primary outcomes:
measure: Decrease in HbA1c
timeFrame: 90 days
measure: Decrease in LDL Cholesterol
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Federal Hospital
state: Nevada
Study officials:
affiliation: Mike O'Callaghan Federal Hospital/Nellis Air Force Base
name: Paul Crawford, M.D.
role: PRINCIPAL_INVESTIGATOR
References: