Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin for Treatment of Type 2 DM.

Mike O'Callaghan Military Hospital

Status: Terminated

Conditions: Diabetes

Treatments: Drug: Group 1: Metformin; Dietary Supplement: Group 3: Cinnulin PF; Dietary Supplement: Group 2: Cinnamon Bark

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01302743

FWH20110004H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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25 participants in 3 patient groups

Metformin

Active Comparator group

Description:

oral extended-release Metformin 1000 mg once a day for 90 days

Treatment:

Drug: Group 1: Metformin

Cinnamon Bark

Experimental group

Description:

Cinnamon Bark 1000 mg once a day for 90 days

Treatment:

Dietary Supplement: Group 2: Cinnamon Bark

Cinnulin PF

Experimental group

Description:

Cinnulin PF 500 mg once a day for 90 days

Treatment:

Dietary Supplement: Group 3: Cinnulin PF