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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 October 2014 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: October 10, 2014
Last verified: October 2014

February 18, 2011
October 10, 2014
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).
  • Women of childbearing potential will have a serum pregnancy test • 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):

  • Subjects will complete the RAND 36 Item Health Survey.
  • Subjects will be into one of two groups (research-driven):

    • Group 1: Will take 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 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 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
    • Hemoglobin A1c
    • Lipid panel via

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

  • 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
    • Hemoglobin A1c
    • Lipid panel

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

  • Subjects will have an electrocardiogram performed.
  • 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
    • Hemoglobin A1c
    • Lipid panel

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

  • Subjects will have an electrocardiogram performed.
  • Subjects will be told to fast for at least 10 hours prior to Visit 5.
  • Refill water-soluble cinnamon extract or placebo .
  • Subjects will have standard of care blood test drawn to include:

    • Fasting comprehensive metabolic panel
    • Hemoglobin A1c
    • Lipid panel

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

  • Subjects will complete the RAND 36 Item Health Survey.
  • Subjects will have an electrocardiogram performed.
  • 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
    • Hemoglobin A1C
    • Lipid panel

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

  • Subjects will have an electrocardiogram performed.
  • 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
    • Hemoglobin A1c
    • Lipid panel

Visit 7-Month 21- (180 days after Visit 6):

  • 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
    • Hemoglobin A1c
    • Lipid panel

Visit 8-Month 27 (180 days after Visit 7):

  • 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
    • Hemoglobin A1c
    • Lipid panel

Visit 9-Month 33 (180 days after Visit 8):

  • Subjects will be told to fast for at least 10 hours prior to Visit 10.
  • Subjects will have research-driven blood tests drawn which include:

    • Fasting plasma glucose
    • Hemoglobin A1c
    • Lipid panel

Visit 10-Month 39 (180 days after Visit 9):

  • Subjects will complete the RAND 36 Item Health Survey.
  • Subjects will have standard of care blood test drawn which include:

    • Fasting glucose
    • Hemoglobin A1c
    • Lipid panel
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 36 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 2 years 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 2 years 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
October 2014

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