DiabetesNCT01302743
Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin for Treatment of Type 2 DM.
A study testing Group 1: Metformin, Group 2: Cinnamon Bark and Group 3: Cinnulin PF in people with Diabetes, run by Mike O'Callaghan Military Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Group 1: Metformin, Group 2: Cinnamon Bark and Group 3: Cinnulin PF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Federal Hospital
Nellis Air Force Base, Nevada, 89191
About this study
Official title: Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus: A Randomized, Controlled Trial.
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Group 1: Metformin, Group 2: Cinnamon Bark, Group 3: Cinnulin PF
- Keywords
- Diabetes, Metformin, Cinnamon
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: MetforminDrug
Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days
Group 2: Cinnamon BarkDietary supplement
Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days
Group 3: Cinnulin PFDietary supplement
Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | oral extended-release Metformin 1000 mg once a day for 90 days Receives: Drug: Group 1: Metformin |
| Cinnamon Bark | Experimental | Cinnamon Bark 1000 mg once a day for 90 days Receives: Dietary Supplement: Group 2: Cinnamon Bark |
| Cinnulin PF | Experimental | Cinnulin PF 500 mg once a day for 90 days Receives: Dietary Supplement: Group 3: Cinnulin PF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul Crawford, M.D., Principal investigator, Mike O'Callaghan Federal Hospital/Nellis Air Force Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302743
- Sponsor's protocol ID
- FWH20110004H
- Status last verified
- May 2017
- First submitted
- 17 Feb 2011
- Last updated
- 26 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cinnamon Bark, Water-Soluble Cinnamon Extract, and Metformin as Initial Treatment for Type 2 Diabetes Mellitus: A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01302743
- Acronym / sponsor ID
- FWH20110004H
- Conditions
- Diabetes
- Keywords
- Diabetes, Metformin, Cinnamon
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- Nov 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Posted 28 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Group 1: Metforminoral extended-release Metformin 1000 mg once a day for 90 days |
| Cinnamon Bark | Experimental | Dietary Supplement: Group 2: Cinnamon BarkCinnamon Bark 1000 mg once a day for 90 days |
| Cinnulin PF | Experimental | Dietary Supplement: Group 3: Cinnulin PFCinnulin PF 500 mg once a day for 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1: MetforminGroup 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days | Drug | Metformin |
| Group 2: Cinnamon BarkGroup 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days | Dietary supplement | Cinnamon Bark |
| Group 3: Cinnulin PFGroup 3: Will receive Cinnulin PF 500 mg once a day for 90 days. | Dietary supplement | Cinnulin PF |
Primary outcome
Decrease in HbA1c
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Crawford, M.D. principal investigator
Mike O'Callaghan Federal Hospital/Nellis Air Force Base
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: Metformin, Group 2: Cinnamon Bark and Group 3: Cinnulin PF in people with Diabetes, run by Mike O'Callaghan Military Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in HbA1c (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.