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

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mike O'Callaghan Federal Hospital; Mike O'Callaghan Military Hospital
• Treatments: Metformin

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