Effects of Cinnamon Supplementation on Glucose Metabolism in Patients With Pre-diabetes

Description

The transition from normal glucose tolerance to overt type 2 diabetes mellitus (T2D) encompasses a variety of glycemic abnormalities that are commonly referred to as 'prediabetes'. While intensive lifestyle interventions are the cornerstone of T2D prevention, developing safe, cost-effective adjunct therapeutic strategies is a clinically relevant goal. Cinnamon supplementation has been shown to improve fasting plasma glucose in patients with T2D. This placebo-controlled, randomized study will determine if cinnamon improves glucose homeostasis in patients with prediabetes over a 12-week period.

Study Start Date

August, 24 2017

Estimated Completion Date

June 2018

Interventions

  • Other: placebo
  • Dietary Supplement: Cinnamon

Study ID

Joslin Diabetes Center -- CHS #:2017-15

Status

Recruiting

Trial ID

NCT03219411

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

12

Sponsor

Joslin Diabetes Center

Inclusion Criteria

    1. Ages 20
  • 70 years old at screening 2. Meet at least one of the following criteria of Prediabetes according to the 2016 American Diabetes Association criteria: 1. Impaired Fasting Glucose (IFG [100-125 mg/dL]) 2. Impaired Glucose Tolerance (IGT [2-h plasma glucose: 140-199 mg/dL based on 75-g OGTT]) 3. HbA1c between 5.7-6.4% 3. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

Exclusion Criteria

    1. Documented diabetes mellitus diagnosed by a physician and confirmed by other clinical data. 2. Previous use of any antidiabetic medication. 3. Cardiovascular disease within 6 months of the study commencement including arrhythmia, congestive heart failure, myocardial infarction or pacemaker placement. 4. History of uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg on three or more assessments on more than 1 day). If the patient is on blood pressure medications, dosing should be stable for at least 4 weeks prior to randomization. 5. Cancer diagnosis requiring treatment in the past 5 years 6. Chronic kidney disease stage 3-5 (estimated glomerular filtration rate < 60 based on MDRD formula or creatinine ? 1.4 for men or >1.3 mg/dL for women, or a urine protein ? 2+) 7. Known liver disease or elevation of AST, ALT, or GGT > 2.50 × upper limit of normal at screening. 8. Other gastrointestinal diseases (including pancreatitis and inflammatory bowel disease) 9. Participation in other clinical trials within 2 months. 10. Surgery within 30 days prior to screening. 11. Pulmonary disease with dependence on oxygen or daily use of bronchodilators. 12. Chronic infections (e.g., human immune-deficiency virus (HIV) or active tuberculosis) 13. Allergy or hypersensitivity to any of the ingredients in the test products. 14. Cognitive impairment or any other reason to expect the patient would have difficulty complying with study protocol 15. Excessive alcohol intake defined as greater than 3 units of alcohol per day. 16. Use of weight loss drugs (e.g., lorcaserin [Belviq] phentermine/topiramate [Qsymia], liraglutide [Saxenda], Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanol-amine], or similar over-the-counter medications) within 3 months of the screening visit. 17. Intentional weight loss of ? 10 lbs in the previous 6 months. 18. Use of dietary supplements that may have glucose-lowering effects (e.g. Sesame, Polygonatum odoratum, Chromium, Vanadium). 19. Concurrent enrollment in a weight loss program, such as Weight Watchers. 20. Other endocrine disorders affecting glucose metabolism including Cushing' syndrome, acromegaly, hyperthyroidism, hypothyroidism or adrenal insufficiency. 21. Fasting plasma triglyceride >500 mg/dl. 22. Oral corticosteroids within 3 months. 23. Pregnancy and/ or Lactation: Women of childbearing potential will be required to have a negative urine pregnancy test and to use contraception measures during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence. 24. Moderate anemia, defined as hemoglobin <10.9 in both men and women based on WHO criteria

Gender

All

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Casey Holden RN 617-309-4314 casey.holden@joslin.harvard.edu
Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Casey Holden RN 617-309-4314 casey.holden@joslin.harvard.edu
Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Casey Holden RN 617-309-4314 casey.holden@joslin.harvard.edu
Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Casey Holden RN 617-309-4314 casey.holden@joslin.harvard.edu
Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Casey Holden RN 617-309-4314 casey.holden@joslin.harvard.edu

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