Diabetes Mellitus, Adult OnsetPhase 2NCT00237640
Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus
A Phase 2 study of Diabetes Mellitus, Adult Onset, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of cinnamon on serum glucose and lipid levels in people with non-insulin dependent type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Adult Onset
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Type 2 diabetes mellitus
- HbA1C > 6.0%
- Age 18 and above
- Able to obtain consent
Who cannot join
- Currently taking insulin
- Pregnancy
- End-stage renal disease
- Hemolytic anemia
- Cinnamon intolerance
- Inability or unwillingness to adhere to study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center
Oklahoma City, Oklahoma, 73117
About this study
The purpose of this study is to determine the effects of cinnamon on serum glucose and lipid levels in people with non-insulin dependent type 2 diabetes mellitus.
Read the detailed description
Forty people with non-insulin dependent type 2 diabetes mellitus will be randomized to receive either cinnamon or placebo for three months. The dose of cinnamon will be one gram daily. Fasting serum glucose, triglyceride, total cholesterol, LDL, HDL, and insulin levels will be measured at baseline and at 1, 2, and 3 months. HbA1c levels will be measured at baseline and at 3 months. Patients will be monitored for compliance, adverse effects, and dietary changes.
- Conditions
- Diabetes Mellitus, Adult Onset
- Being tested
- Cinnamon or placebo 500 mg capsule twice daily
- Keywords
- Cinnamon, Diabetes mellitus, Hyperlipidemia, Insulin Resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hyperlipidemias, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinnamon or placebo 500 mg capsule twice dailyDrug
Cinnamon 500 mg capsule twice daily or placebo capsule twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Cinnamon or placebo 500 mg capsule twice daily |
| 2 | Active comparator | Not described Receives: Drug: Cinnamon or placebo 500 mg capsule twice daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startMar 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Adult OnsetStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- Steve M Blevins, M.D., Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237640
- Sponsor's protocol ID
- 11798
- Status last verified
- Sep 2008
- First submitted
- 10 Oct 2005
- Last updated
- 22 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Blevins SM, Leyva MJ, Brown J, Wright J, Scofield RH, Aston CE. Effect of cinnamon on glucose and lipid levels in non insulin-dependent type 2 diabetes. Diabetes Care. 2007 Sep;30(9):2236-7. doi: 10.2337/dc07-0098. Epub 2007 Jun 11. No abstract available.
PubMed 17563345
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00237640
- Acronym / sponsor ID
- 11798
- Conditions
- Diabetes Mellitus, Adult Onset
- Keywords
- Cinnamon, Diabetes mellitus, Hyperlipidemia, Insulin Resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Mar 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
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 determine the effects of cinnamon on serum glucose and lipid levels in people with non-insulin dependent type 2 diabetes mellitus.
Detailed description
Forty people with non-insulin dependent type 2 diabetes mellitus will be randomized to receive either cinnamon or placebo for three months. The dose of cinnamon will be one gram daily. Fasting serum glucose, triglyceride, total cholesterol, LDL, HDL, and insulin levels will be measured at baseline and at 1, 2, and 3 months. HbA1c levels will be measured at baseline and at 3 months. Patients will be monitored for compliance, adverse effects, and dietary changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Cinnamon or placebo 500 mg capsule twice daily |
| 2 | Active comparator | Drug: Cinnamon or placebo 500 mg capsule twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes mellitus
- HbA1C > 6.0%
- Age 18 and above
- Able to obtain consent
Key exclusion criteria (6 listed)
- Currently taking insulin
- Pregnancy
- End-stage renal disease
- Hemolytic anemia
- Cinnamon intolerance
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 |
|---|---|---|
| Cinnamon or placebo 500 mg capsule twice dailyCinnamon 500 mg capsule twice daily or placebo capsule twice daily | Drug | 1, 2 |
Primary outcome
- Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2008.
- Derived from this study: PubMed 17563345Blevins SM, Leyva MJ, Brown J, Wright J, Scofield RH, Aston CE. Effect of cinnamon on glucose and lipid levels in non insulin-dependent type 2 diabetes. Diabetes Care. 2007 Sep;30(9):2236-7. doi: 10.2337/dc07-0098. Epub 2007 Jun 11. No abstract available.
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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.
Steve M Blevins, M.D. principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Diabetes Mellitus, Adult Onset, run by University of Oklahoma 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Sep 2008. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
- Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00237640, which also lists 1 linked publication.
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 22 Sep 2008.