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

• Status: Completed
• Trial end date: 2019-04-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mike O'Callaghan Federal Hospital; Mike O'Callaghan Military Hospital

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