Diabetes
Conditions
Keywords
Diabetes, Metformin, Cinnamon
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.
Interventions
DRUGGroup 1: Metformin
Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days
DIETARY_SUPPLEMENTGroup 2: Cinnamon Bark
Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days
DIETARY_SUPPLEMENTGroup 3: Cinnulin PF
Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.
Sponsors
Mike O'Callaghan Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in HbA1c | 90 days | Subjects will have baseline blood levels to measure HbA1c. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again. |
| Decrease in LDL Cholesterol | 90 days | Subjects will have baseline blood levels to measure LDL Cholesterol. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metformin oral extended-release Metformin 1000 mg once a day for 90 days
Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days | 7 |
| Cinnamon Bark Cinnamon Bark 1000 mg once a day for 90 days
Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days | 8 |
| Cinnulin PF Cinnulin PF 500 mg once a day for 90 days
Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days. | 10 |
| Total | 25 |
Baseline characteristics
| Characteristic | Metformin | Cinnamon Bark | Cinnulin PF | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 2 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 | 0 / 10 |
| other Total, other adverse events | 0 / 7 | 0 / 8 | 0 / 10 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 | 0 / 10 |
Outcome results
Primary
Decrease in HbA1c
Subjects will have baseline blood levels to measure HbA1c. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.
Time frame: 90 days
Population: no data was analyzed as study was stopped early due to low recruitment
Primary
Decrease in LDL Cholesterol
Subjects will have baseline blood levels to measure LDL Cholesterol. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.
Time frame: 90 days
Population: no data was analyzed as study was stopped early due to low recruitment
| Arm | Measure | Value |
|---|---|---|
| Metformin | Decrease in LDL Cholesterol | 0 |
| Cinnamon Bark | Decrease in LDL Cholesterol | 0 |
| Cinnulin PF | Decrease in LDL Cholesterol | 0 |