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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dysglycemia, Obesity

In brief

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.

Key facts

Study ID

NCT03219411

Run by

Joslin Diabetes Center

People needed

12

Starts

2017-08-28

Expected to finish

2019-07-30

Last updated by the study team

2019-08-19

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Documented diabetes mellitus diagnosed by a physician and confirmed by other clinical data.
• Previous use of any antidiabetic medication.
• Cardiovascular disease within 6 months of the study commencement including arrhythmia, congestive heart failure, myocardial infarction or pacemaker placement.
• 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.
• Cancer diagnosis requiring treatment in the past 5 years
• 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+)
• Known liver disease or elevation of AST, ALT, or GGT > 2.50 × upper limit of normal at screening.
• Other gastrointestinal diseases (including pancreatitis and inflammatory bowel disease)
• Participation in other clinical trials within 2 months.
• Surgery within 30 days prior to screening.
• Pulmonary disease with dependence on oxygen or daily use of bronchodilators.
• Chronic infections (e.g., human immune-deficiency virus (HIV) or active tuberculosis)
• Allergy or hypersensitivity to any of the ingredients in the test products.
• Cognitive impairment or any other reason to expect the patient would have difficulty complying with study protocol
• Excessive alcohol intake defined as greater than 3 units of alcohol per day.
• 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.
• Intentional weight loss of ≥ 10 lbs in the previous 6 months.
• Use of dietary supplements that may have glucose-lowering effects (e.g. Sesame, Polygonatum odoratum, Chromium, Vanadium).
• Concurrent enrollment in a weight loss program, such as Weight Watchers.
• Other endocrine disorders affecting glucose metabolism including Cushing' syndrome, acromegaly, hyperthyroidism, hypothyroidism or adrenal insufficiency.
• Fasting plasma triglyceride >500 mg/dl.
• Oral corticosteroids within 3 months.
• 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.
• Moderate anemia, defined as hemoglobin <10.9 in both men and women based on WHO criteria

Where it is running

• Joslin Diabetes Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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