Conditions: Diabetes
Keywords: Diabetes Metformin Cinnamon
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

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.

Arms:
arm 1: oral extended-release Metformin 1000 mg once a day for 90 days arm 2: Cinnamon Bark 1000 mg once a day for 90 days arm 3: Cinnulin PF 500 mg once a day for 90 days

Interventions: intervention 1: Group 1: Metformin intervention 2: Group 2: Cinnamon Bark intervention 3: Group 3: Cinnulin PF
Intervention descriptions: intervention 1: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days intervention 2: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days intervention 3: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.

Protocol document: