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

NCT03219411 | Completed Phase 2 DMC

• 1 other identifier: CHS #:2017-15
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysglycemia; Obesity

Outcome Measures

Primary Outcomes (1)

• Fasting plasma glucose at 12 weeks

  Change from baseline in fasting plasma glucose at 12 weeks

  12 weeks

Secondary Outcomes (3)

• Fasting plasma glucose at 6 weeks

  6 weeks

• 2-hour plasma glucose during OGTT (oral glucose tolerance test)

  12 weeks

• Area under the curve-glucose during OGTT (oral glucose tolerance test)

  12 weeks

Study Arms (2)

Cinnamon

ACTIVE COMPARATOR

Cinnamon burmannii administered orally as 500-mg capsules three times daily over 12 weeks

Dietary Supplement: Cinnamon

Placebo

PLACEBO COMPARATOR

Placebo administered orally as capsules three times daily over 12 weeks

Other: placebo

Interventions

Cinnamon DIETARY_SUPPLEMENT

Cinnamon burmannii administered orally as 500-mg capsules three times a day over 12 weeks

Cinnamon

placebo OTHER

Placebo administered orally as capsules three times a day over 12 weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Kyunghee University: collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (3)

• Medagama AB. The glycaemic outcomes of Cinnamon, a review of the experimental evidence and clinical trials. Nutr J. 2015 Oct 16;14:108. doi: 10.1186/s12937-015-0098-9.

  PMID: 26475130 BACKGROUND

• Hlebowicz J, Hlebowicz A, Lindstedt S, Bjorgell O, Hoglund P, Holst JJ, Darwiche G, Almer LO. Effects of 1 and 3 g cinnamon on gastric emptying, satiety, and postprandial blood glucose, insulin, glucose-dependent insulinotropic polypeptide, glucagon-like peptide 1, and ghrelin concentrations in healthy subjects. Am J Clin Nutr. 2009 Mar;89(3):815-21. doi: 10.3945/ajcn.2008.26807. Epub 2009 Jan 21.

  PMID: 19158209 BACKGROUND

• Khan A, Safdar M, Ali Khan MM, Khattak KN, Anderson RA. Cinnamon improves glucose and lipids of people with type 2 diabetes. Diabetes Care. 2003 Dec;26(12):3215-8. doi: 10.2337/diacare.26.12.3215.

  PMID: 14633804 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giulio R Romeo, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 17, 2017
• Study Start: August 28, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 30, 2019
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)