Cinnamon Trial—Assessment of the effeCt of lIfestyle iNtervention Plus Water-soluble ciNnAMon Extract On loweriNg Blood Glucose in Pre-diabetics: A Randomized, Double-blind, Multicenter, Placebo Controlled TRIAL.
|First Received Date ICMJE||February 18, 2011|
|Last Updated Date||April 19, 2012|
|Start Date ICMJE||June 2012|
|Estimated Primary Completion Date||July 2016 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||water-soluble cinnamon [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Does water-soluble cinnamon extract delay the onset of diabetes or extend the time to diagnosis of diabetes in pre-diabetic patients who are already undergoing aggressive lifestyle therapy?
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01301521 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Cinnamon Trial—Assessment of the effeCt of lIfestyle iNtervention Plus Water-soluble ciNnAMon Extract On loweriNg Blood Glucose in Pre-diabetics: A Randomized, Double-blind, Multicenter, Placebo Controlled TRIAL.|
|Official Title ICMJE||Cinnamon Trial—Assessment of the effeCt of lIfestyle iNtervention Plus Water-soluble ciNnAMon Extract On loweriNg Blood Glucose in Pre-diabetics: A Randomized, Double-blind, Multicenter, Placebo Controlled TRIAL.|
The purpose of this study is to assess whether water-soluble cinnamon extract plus aggressive lifestyle intervention is effective in lowering blood glucose in pre-diabetic patients when compared to aggressive lifestyle therapy plus placebo.
We will recruit male and female subjects (MOFH, Keesler, WHMC, WPAFB, DGMC, Eglin and Offutt DoD beneficiaries) over the age of 18 with a diagnosis of pre-diabetes. Eligible subjects will be recruited either 4 weeks prior to or 4 weeks after their first weekly or monthly Group Lifestyle Balance (GLB) class.
Visit 1 (Day 1-< 1 week of Screening Visit):
Visit 2-Month 3 (90 days after Visit 1):
Visit 3-Month 6 (90 days after Visit 2):
Visit 4-Month 12 (6 months after Visit 3):
Visit 5-Month 18- (6 months after Visit 4):
Visit 6-Month 24 (6 months after Visit 5):
Visit 7-Month 30 (6 months after Visit 6):
Visit 8-Month 36 (6 months after Visit 7):
Visits 2-8 have a window of plus or minus 10 days. Postponement of any 6 month periodic visit is authorized for up to 6 weeks in case of a temporary condition that would affect glucose tolerance (i.e. moderate to severe illness to be determined by study PI or Site AI). A note to file documenting such shall be placed in the subjects study folder and documented in the data collection form.
ADHERENCE TO STUDY ASSIGNMENTS:
Adherence to water-soluble cinnamon extract or placebo will be assessed via pill counts. Subjects will be instructed to bring back all of the bottles regardless of whether there are empty or contain missed doses.
If at any time a patient stops taking their water-soluble cinnamon extract or placebo, they will remain in the study and will be instructed to return any pill bottles and will continue follow up in the study; however, Study Staff will contact them every 6 months with the opportunity to re-start their water-soluble cinnamon extract or placebo. If the subject decides to re-start their water-soluble cinnamon extract or placebo, they will resume the study at the visit that they would have been had they stayed in the study (i.e. subject stops taking water-soluble cinnamon extract or placebo at Visit 4 and decides 1 year later that they wish to resume the study, their next visit would be Visit 6).
DIRECTIONS FOR TAKING MEASUREMENTS:
A measuring tape to measure subject's waist circumference will be provided. A designated study staff member will obtain the waist circumference measurements to ensure consistent measurements throughout the study.
Directions for taking waist circumference measurement: have patients take a deep breath, blow out and hold with abdominals tightened. Tell patients not to suck in their stomach. Take the measurement around the largest part of their waist. Waist Circumference should be recorded to the nearest ½ inch (for example: 40.5)
Directions for weighing subjects: have patients remove their shoes and empty their pockets of any items prior to stepping on scale. Weight should be recorded to the nearest ½ pound (for example: 150.5)
Directions for taking height: have patients remove their shoes before taking their height. Height should be recorded to the nearest 1/2 inch (for example: 60.5)
WITHDRAWAL PROCEDURES. If at any time during the study, the subject decides to withdraw consent or if the subject has abnormal laboratory values, they will be referred to their Primary Care Manager (PCM) to initiate standard of care treatment. If a subject is found to be diabetic during the course of the study, they will be withdrawn and referred to their PCM to initiate standard of care treatment. No final withdrawal visits are necessary. If a subject becomes pregnant during the study, they will be withdrawn from the study and referred to their PCM for standard of care treatment.
ADVERSE EVENTS (AEs) AND DEVIATIONS:
The Associate Investigator (AI) at each site is responsible for reviewing, categorizing, and properly reporting to the main PI AEs that occur with their subjects.
Serious Adverse Events and Deviations:
Serious adverse events (SAEs) are defined as unexpected events that increase the risk to subjects and that were possibly, probably or definitely related to the research. SAEs must be reported to the WHMC IRB within 5 days, therefore site AI's are responsible for reporting SAEs to the Principal Investigator and Clinical Research Coordinator of this study, immediately via the "Notification of Internal Reportable Unanticipated Problem" form.
Adverse Events and Deviations:
AE's and deviations that do not increase the risks to subjects like those listed in the "risks" section of this protocol are to be reported to the Principal Investigator and Clinical Research Coordinator of this study the 1st workday of every month via the "WHMC Tracking Log for Problems Not Requiring Immediate Reporting". This is done to ensure ongoing monitoring and identification of trends that may arise.
Subjects must agree to take precautions to prevent pregnancy during the course of this study due to the possible effect water soluble cinnamon extract may cause an unborn child. The only completely reliable methods of birth control are total abstinence or surgical removal of the uterus. Other methods, such as the use of condoms, a diaphragm or cervical cap, birth control pills, IUD, or sperm killing products are not totally effective in preventing pregnancy. Also, women who are breastfeeding may not participate in this study.
If a subject unintentional becomes pregnant, they will be instructed to cease water-soluble cinnamon extract or placebo, return any pill bottles and will continue follow up in the study. They will be encouraged to resume taking water-soluble cinnamon extract or placebo and blood work (if they choose) 6 months after delivery of their child. If the subject decides to re-start their water-soluble cinnamon extract or placebo, they will resume the study at the visit that they would have been had they stayed in the study (i.e. subject stops taking water-soluble cinnamon extract or placebo at Visit 4 and decides 1 year later that they wish to resume the study, their next visit would be Visit 6).
A study-specific email address has been established (email@example.com). Subjects with access to email will be sent a quarterly newsletter similar to the newsletters found on the American Diabetes Association Website (ADA) http://www.diabetes.org/assets/pdfs/winning-at-work/newletterarticle-1.pdf. The intent of the newsletter is to encourage a sense of community within the research trial and to improve retention. The main study site will be responsible for creating and sending the newsletter each quarter.
SUBJECTS COMPLETING THE STUDY:
When subjects have completed the study (Visit 8-Month 36), the Pharmacy will then de-identify the information and send to the Investigator for analysis. Each Associate Investigator will send the de-identified data to the Principal Investigator via an encrypted email for analysis.
Subjects will be given a card to remind them that they will be getting blood tests every 6 months as part of this study. They are requested to show this to PCM any time labs are ordered to avoid any duplication of standard of care labs.
Subjects will take their water-soluble cinnamon extract or placebo daily and will be permitted to have the usual medical care for other co-morbid and acute conditions if applicable. 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).
Subject's participation in this study is completed after Visit 8-Month 36.
The Placebo will be a gelatin capsule filled with starch which does not increase the risks to subjects.
Aggressive lifestyle therapy is defined as attendance in the Group Lifestyle Balance (GLB) CD-based class. The Group Lifestyle Balance (GLB) Program is a group-based lifestyle behavioral change program delivered in either weekly or monthly group sessions created from the Diabetes Prevention Program at University of Pittsburgh. The focus of this program is to teach participants on how to make healthy food choices and how to monitor calorie and fat intake by reading the dietary guidelines on packaging of food items. Participants are given food logs to aid them in tracking their eating habits and fat/calorie intake and a pedometer to help them increase their physical activity level. To learn more please visit: http://www.diabetesprevention.pitt.edu/diabetesPrevention_ServicesOffered.htm
Each site's Laboratory will be responsible for analyzing blood samples obtained at their site for this study. Samples will be labeled as they would for standard laboratory draws. All Laboratories are Clinical Laboratory Improvement Amendments (CLIA) certified and will use these procedures when processing Laboratory specimens mentioned in this research project.
Water soluble cinnamon extract (Cinnulin PF) is not being used in this study to treat diabetes or prediabetes. It is being used to assess its effects on insulin in prediabetic patients. It is being given in a dose that does not increase the risk to the research subjects. There are no known risks associated with water-soluble cinnamon as it is a compound granted GRAS (Generally Recognized As Safe) status by the United States Food and Drug Administration (more information can be found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=582.20). Water soluble cinnamon extract is exempt from the applicability of 21 CFR 312.2(b)(i-v), Investigational New Drug Application, because the investigation is not intended to be reported to the FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling; water soluble cinnamon extract is lawfully marketed as a dietary supplement, the investigation is not intended to support a significant change in the advertising for the product; the investigation does not involve administration that significantly increases/decreases the risks associated with its use; the investigation is conducted in compliance with the requirements for institutional review set forth in part 56 and with the requirements for informed consent set forth in part 50; and the investigation is conducted in compliance with the requirements of 312.7. An email from Integrity Nutraceuticals is attached stating that they are not pursuing a change in labeling.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Intervention ICMJE||Drug: water-soluble cinnamon extract (Cinnulin PF)
Will take (by mouth) 1 gelatin capsule that contains 1 gram water-soluble cinnamon extract (Cinnulin PF) once a day for 36 months plus standard of care aggressive lifestyle therapy
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||2200|
|Estimated Completion Date||July 2016|
|Estimated Primary Completion Date||July 2016 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01301521|
|Other Study ID Numbers ICMJE||FWH20110035H|
|Has Data Monitoring Committee||No|
|Responsible Party||Mike O'Callaghan Federal Hospital|
|Study Sponsor ICMJE||Mike O'Callaghan Federal Hospital|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Mike O'Callaghan Federal Hospital|
|Verification Date||April 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP