Cinnamon Trial-lIfestyle iNtervention Plus Water-soluble Cinnamon Extract On loweriNg Blood Glucose in Pre-diabetics

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Mike O'Callaghan Federal Hospital
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Federal Hospital
ClinicalTrials.gov Identifier:
NCT01301521
First received: February 18, 2011
Last updated: February 6, 2015
Last verified: February 2015

February 18, 2011
February 6, 2015
November 2010
July 2016   (final data collection date for primary outcome measure)
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?
Same as current
Complete list of historical versions of study NCT01301521 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cinnamon Trial-lIfestyle iNtervention Plus Water-soluble Cinnamon Extract On loweriNg Blood Glucose in Pre-diabetics
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.

Screening Visit:

  • Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).
  • Record: Date of birth, gender, race, ethnicity, name of lifestyle intervention for pre-diabetes, current email address height (in inches), weight (in pounds), waist circumference (in inches) measurement, blood pressure, and whether subject is taking any statins, fibrate, niacin or bile acid binding agent and, if yes, the name of drug, strength and dose.
  • Women of childbearing potential will have a serum pregnancy test (5-10 milliliters (mls), approximately 1-2 teaspoons of blood) (research-driven).
  • Subjects will be told to fast for at least 10 hours prior to Visit 1.

Visit 1 (Day 1 within 1 week of Screening Visit):

  • Record: whether subject is taking any statins, fibrate, niacin or bile acid binding agent and, if yes, the name of drug, strength and dose.
  • Subjects will complete the RAND 36 Item Health Survey.
  • Subjects will be randomized by a non-investigator at the pharmacy. We will use a random-number generator and use blocking to ensure roughly equal sample sizes. Both subjects and investigators will be blinded to the study group assignments. Subjects will be randomized by the pharmacy into one of two groups (research-driven):

    • Group 1: Will take (by mouth) 2 gelatin capsules that contains 1 gram (2-500 mg capsules) water-soluble cinnamon extract (Cinnulin PF) once a day for 1 year plus 2 years of follow-up plus standard of care aggressive lifestyle therapy.
    • Group 2: Will take (by mouth) 2 placebo capsules (gelatin capsule filled with wheat bran) once a day for 1 year plus 2 years of follow-up plus standard of care aggressive lifestyle therapy.
  • Subjects will be provided a pill container to assist with remembering to take their IP and a bathroom scale to weigh themselves with.

    • If subject is a DoD beneficiary, they will keep the pill container and bathroom scale.
    • If subject is active duty or a DoD employee, Research staff will complete Temporary Issue Receipt and retain in a separate file. Instruct the subject that they will be asked to bring the pill containers and bathroom scale back when their participation in the study ends.
  • Subjects will be given their "Blood Test Reminder Card" and will be instructed to show it to their PCM when blood work is being ordered in order to avoid duplicate standard of care labs from being drawn.
  • Subjects will have an electrocardiogram performed.
  • Subjects will be given a Study Medication Diary and will be instructed to bring it with them to next study visit.
  • Subjects will be told to fast for at least 10 hours prior to Visit 2.
  • Subjects will have the following research-driven blood test drawn which include:

    • Fasting comprehensive metabolic panel (liver function, renal function, plasma glucose tests) via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Hemoglobin A1c via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn)
    • Lipid panel via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn)

Visit 2-Month 3 (90 days after Visit 1):

  • Record: Weight (in pounds), waist circumference (in inches), blood pressure, verify current email address , and whether subject is taking any statins, fibrate, niacin or bile acid binding agent and, if yes, the name of drug, strength and dose.
  • .
  • Study staff will record whether subject had any side effects to report to include cardiovascular procedures and events and other morbidity data (research-driven).
  • Subjects will bring in any remaining medication to determine adherence rates to the study protocol.
  • Research staff will collect the subject's Study Medication Diary and issue them a new one.
  • Subjects will have an electrocardiogram performed.
  • Subjects will be told to fast for at least 10 hours prior to Visit 3.
  • Refill water-soluble cinnamon extract or placebo (research-driven).
  • Subjects will have standard of care blood test drawn to include:

    • Fasting comprehensive metabolic panel (liver function tests, renal function, and plasma glucose test) via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Hemoglobin A1c via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn)
    • Lipid panel via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn)

Visit 3-Month 6 (90 days after Visit 2):

  • Record: Weight (in pounds), waist circumference (in inches), blood pressure, verify current email address , and whether subject is taking any statins, fibrate, niacin or bile acid binding agent and, if yes, the name of drug, strength and dose..
  • Study staff will record whether subjects had any side effects to report to include cardiovascular procedures and events and other morbidity data (research-driven).
  • Subjects will bring in any remaining medication to determine adherence rates to the study protocol.
  • Research staff will collect the subject's Study Medication Diary and issue them a new one.
  • Subjects will be told to fast for at least 10 hours prior to Visit 4.
  • Refill water-soluble cinnamon extract or placebo (research-driven).
  • Subjects will have research-driven blood test drawn which include:

    • Fasting comprehensive metabolic panel (liver function tests, renal function, and plasma glucose test) via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Hemoglobin A1c via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Lipid panel via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).

Visit 4-Month 9 (90 days after Visit 3):

  • Record weight (in pounds), waist circumference) (in inches), blood pressure, verify current email address , and whether subject is taking any statins, fibrate, niacin or bile acid binding agent and, if yes, the name of drug, strength and dose.
  • Study staff will also record whether subjects had any side effects to report to include cardiovascular procedures and events and other morbidity data (research-driven).
  • Subjects will bring in any remaining medication to determine adherence rates to the study protocol.
  • Research staff will collect the subject's Study Medication Diary and issue them a new one.
  • Subjects will be told to fast for at least 10 hours prior to Visit 5.
  • Refill water-soluble cinnamon extract or placebo (research-driven).
  • Subjects will have standard of care blood test drawn to include:

    • Fasting comprehensive metabolic panel (liver function tests, renal function, and plasma glucose test) via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Hemoglobin A1c via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Lipid panel via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).

Visit 5-Month 12 (90 days after Visit 4) *SUBJECTS STOP TAKING STUDY MEDICATIONS AT THIS VISIT:

  • Record weight (in pounds), waist circumference (in inches), blood pressure, verify current email address , and whether subject is taking any statins, fibrate, niacin or bile acid binding agent and, if yes, the name of drug, strength and dose.
  • Record whether subjects had any side effects to report to include cardiovascular procedures and events and other morbidity data (research-driven).
  • Subjects will complete the RAND 36 Item Health Survey.
  • Subjects will bring in any remaining medication to determine adherence rates to the study protocol.
  • Research staff will collect the subject's Study Medication Diary.
  • Subjects will be told to fast for at least 10 hours prior to Visit 6.
  • Subjects will have research-driven labs drawn which include:

    • Fasting comprehensive metabolic panel (liver function, renal function, and plasma glucose) via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Hemoglobin A1C via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Lipid panel via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).

Visit 6-Month 15 (90 days after Visit 5):

  • Record weight (in pounds), waist circumference (in inches), blood pressure, verify current email address , and whether subject is taking any statins, fibrate, niacin or bile acid binding agent and, if yes, the name of drug, strength and dose.
  • Record whether subjects had any side effects to report to include cardiovascular procedures and events and other morbidity data (research-driven).
  • Subjects will be told to fast for at least 10 hours prior to Visit 7.
  • Subjects will have standard of care blood tests drawn including:

    • Fasting comprehensive metabolic panel (liver function tests, renal function, and plasma glucose) via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Hemoglobin A1c via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Lipid panel via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).

Visit 7-Month 18- (90 days after Visit 6):

  • Record weight (in pounds), waist circumference (in inches), blood pressure, verify current email address , and whether subject is taking any statins, fibrate, niacin or bile acid binding agent and, if yes, the name of drug, strength and dose.
  • Record whether subjects had any side effects to report to include cardiovascular procedures and events and other morbidity data (research-driven).
  • Subjects will be told to fast for at least 10 hours prior to Visit 8.
  • Subjects will have a research-driven blood tests draw which includes:

    • Fasting plasma glucose via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood).
    • Hemoglobin A1c via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Lipid panel via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).

Visit 8-Month 21 (90 days after Visit 7):

  • Record: Weight (in pounds), waist circumference (in inches), blood pressure, verify current email address , and whether subject is taking any statins, fibrate, niacin or bile acid binding agent and, if yes, the name of drug, strength and dose.
  • Study staff will also record whether subjects had any side effects to report to include cardiovascular procedures and events and other morbidity data (research-driven).
  • Subjects will be told to fast for at least 10 hours prior to Visit 9.
  • Subjects will have standard of care blood test drawn which include:

    • Fasting plasma glucose via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Hemoglobin A1c via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Lipid panel via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).

Visit 9-Month 24 (90 days after Visit 8):

  • Record: Weight (in pounds), waist circumference (in inches), blood pressure, verify current email address , and whether subject is taking any statins, fibrate, niacin or bile acid binding agent and, if yes, the name of drug, strength and dose.
  • Subjects will complete the RAND 36 Item Health Survey.
  • Study staff will also record whether subjects had any side effects to report to include cardiovascular procedures and events and other morbidity data (research-driven).
  • Subjects whom are Active Duty or DoD employees will be asked to return the pill container and bathroom scale. Research staff to complete the Temporary Issue Receipt.
  • Subjects will have research-driven blood tests drawn which include:

    • Fasting plasma glucose via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Hemoglobin A1c via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
    • Lipid panel via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn).
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Diabetes
  • Pre-Diabetes
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 12 months plus standard of care aggressive lifestyle therapy
Other Name: Cinnulin PF
  • Experimental: Cinnulin PF
    Will take (by mouth) 2 gelatin capsules that contains 1 gram (2-500 mg capsules) water-soluble cinnamon extract (Cinnulin PF) once a day for 1 year plus 1 year of follow-up plus standard of care aggressive lifestyle therapy.
    Intervention: Drug: water-soluble cinnamon extract (Cinnulin PF)
  • Placebo Comparator: Placebo
    Will take (by mouth) 2 placebo capsules (gelatin capsule filled with wheat bran) once a day for 1 year plus 1 year of follow-up plus standard of care aggressive lifestyle therapy.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
557
July 2016
July 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jill M Clark, MBA/HCM, CCRP, CCRC 7026533298 jill.clark.3.ctr@us.af.mil
United States
 
NCT01301521
FWH20110035H
No
Mike O'Callaghan Federal Hospital
Mike O'Callaghan Federal Hospital
Not Provided
Principal Investigator: Paul Crawford, M.D. Mike O'Callaghan Federal Hospital/Nellis Air Force Base
Mike O'Callaghan Federal Hospital
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP