CinnamonCinnamon 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.
water-soluble cinnamon extract (Cinnulin PF)
Diabetes Mellitus+4
+ Endocrine System Diseases
+ Hyperglycemia
Prevention Study
Summary
Study start date: June 11, 2013
Actual date on which the first participant was enrolled.We are studying whether water-soluble cinnamon extract (Cinnulin PF) plus standard of care aggressive lifestyle therapy is effective in lowering blood glucose when compared to placebo plus standard of care aggressive life style therapy. Eligible subjects will be recruited from any form and any stage of "standard" lifestyle intervention for pre-diabetes at an individual base. "Standard" lifestyle intervention for pre-diabetes could include Group Lifestyle Balance (GLB), nutrition classes, Better Body/Better Life, or anything an investigator certifies as standard practice at that base. Subjects will take either 1 gram (2-500 milligram (mg) capsules) of water-soluble cinnamon extract (Cinnulin PF) or 2 placebo pills (gelatin capsule filled with wheat bran) once a day for 1 year plus 1 additional year of follow-up. This is a randomized, double-blind, multicenter, placebo-controlled study which will enroll subjects at the Mike O'Callaghan Federal Medical Center (MOFMC), Wilford Hall Ambulatory Surgical Center (WHASC), David Grant Medical Center (DGMC), Eglin Air Force Base (Eglin), and Offutt Air Force Base (Offutt). All subjects will be MOFMC, WHASC, DGMC, Eglin, and Offutt DoD beneficiaries. Informed Consent and HIPAA Authorization will be obtained. After randomization, subjects will receive either 1 gram (2-500 mg capsules) of water-soluble cinnamon extract or placebo from the pharmacy--thus investigators and subjects will be blinded as to if they are taking Cinnulin PF or 2 placebo pills. Subjects will be permitted to have usual medical care for other co-morbid, preventive, and acute conditions. Analysis will be performed using intention-to-treat principles for missing data (the carry-forward method to impute missing data will be used). Subjects will bring in any remaining water-soluble cinnamon extract or placebo to determine adherence rates to the study protocol.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.229 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY. Inclusion: Patients will be MOFMC, WHASC, DGMC, Eglin, and Offutt DoD beneficiaries, ages 18-65 years. Diagnosis of pre-diabetes (defined as a fasting plasma glucose (FPG) 100-125mg/dl, Hemoglobin A1c 5.7-6.4%, or a 2-hour oral glucose tolerance test (OGTT) 140-199). Exclusion: Patients who are less than 18 yrs of age or greater than 65 years of age. Patients who are known to have or develop during the study any of the following upon review of their medical record: * Diabetes Mellitus (defined as fasting plasma glucose (FPG) greater than 126mg/dl, hemoglobin A1C greater than 6.5%, or a 2-hour oral glucose tolerance test (OGTT) greater than 200mg/dl) * Stage 3 kidney disease or worse * Renal insufficiency defined as a glomerular filtration rate (gfr) of less than 60ml * Celiac disease * Insulinoma * Cushing's disease * Hyperthyroidism * Acromegaly * Pheochromocytoma * Addison's disease * Galactosemia * Glycogen storage disease * Hereditary fructose intolerance Patients taking any of the following: * Cinnamon as a dietary supplement * Daily oral steroids * Warfarin * Hypoglycemic medication * Weight loss medication * Digoxin, lithium, phenytoin, \& theophylline (due to their narrow therapeutic indices) Patients who are pregnant or breast feeding Patients with a known allergy to cinnamon Patients with a known allergy to wheat
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Eglin Air Foce Base
Eglin Air Force Base, United StatesOffutt Air Force Base
Offutt Air Force Base, United StatesWilford Hall Ambulatory Surgical Center
Lackland Air Force Base, United States