Effects of Cinnamon Supplementation on Glucose Metabolism in Patients With Pre-diabetes (Cinnamon)
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|ClinicalTrials.gov Identifier: NCT03219411|
Recruitment Status : Active, not recruiting
First Posted : July 17, 2017
Last Update Posted : March 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dysglycemia Obesity||Dietary Supplement: Cinnamon Other: placebo||Phase 2|
BACKGROUND: The transition from normal glucose tolerance and insulin sensitivity to overt type 2 diabetes (T2D) encompasses a variety of glycemic abnormalities that are commonly referred to as 'prediabetes'. In 2003, 314 million people (8.2% of the adult population) had prediabetes, and this number is projected to increase to 472 million (9.0% of the adult population) by 2025. Approximately 40-50% of individuals with prediabetes have been reported to develop T2D within 10 years.
While intensive lifestyle interventions remain the cornerstone of T2D prevention, targeted pharmacotherapy has been shown to be effective and may be considered in high-risk patients. Several antidiabetic medications prevent or, at least, delay the progression from prediabetes to diabetes, including metformin, α-glucosidase inhibitors or pioglitazone. However, cost, potential adverse effects, and secondary failure in the long-term have often limited the widespread use of these and other newer antidiabetic drugs in patients with prediabetes. For instance 10 to 20% of metformin-treated patients experience gastrointestinal side effects (nausea, vomiting, and diarrhea) leading to its discontinuation, whereas the use pioglitazone is often complicated by weight gain and increased risk of fractures.
In this context, efficacious, cost-effective, and safe adjunct therapeutics for T2D prevention are highly desirable. The present trial proposes to test the effects of cinnamon in patients with prediabetes.
RATIONALE: Several randomized controlled studies have addressed the effects of cinnamon on changes in glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) in adult patients with T2D. Almost all studies showed a significant 10-20% decrease in FPG from baseline and improvements in HbA1c, although the latter change often did not achieve statistical significance. These findings in patients with T2D provide the rational to test whether cinnamon exerts similar beneficial effects in patients with prediabetes.
STUDY DESIGN: This is a multi-center placebo-controlled, randomized (1:1), double masked trail to assess the effects of cinnamon (cinnamomum burmannii) on glucose homeostasis over a 12- week period. FPG, HbA1c, and other measures of glucose metabolism will be collected at baseline, after 6 weeks, and at the end of the 12-week study period. Participants will be prompted to report Adverse Events (AE) at the study visits or anytime during the study period.
OUTCOMES: The primary outcome for the Cinnamon Trial is a change in the FPG level from baseline to week 12 of treatment, as compared to placebo. Secondary outcomes include change in the FPG from baseline to week 6 of treatment, and change from baseline in plasma glucose at 2 hours and area under the curve-glucose during a 75-gram oral glucose tolerance test to week 12. Data will be analyzed using the "intent-to-treat" approach, which includes all randomized subjects with at least one post-baseline FPG measurement; the supplementation group assignment will not be altered based on the subject's adherence to the regimen.
SAMPLE SIZE DETERMINATION: Anticipating an absolute change in FPG smaller than what observed in previous studies in patients with T2D, 10 patients with prediabetes in total entering a two-treatment parallel-design study will provide 90% probability of detecting a true between-treatment difference in FPG means of 22 mg/dl with standard deviation of 10 mg/dl, using a paired two-sided comparison with type 1 error of 0.05. To allow for up to 20% dropout, 12 patients in total will be recruited.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind|
|Official Title:||A Multi-National, Double-Blind, Randomized Trial Of The Influence Of Cinnamon Powders In Subjects With Risk For Developing Diabetes|
|Actual Study Start Date :||August 28, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||August 30, 2019|
Active Comparator: Cinnamon
Cinnamon burmannii administered orally as 500-mg capsules three times daily over 12 weeks
Dietary Supplement: Cinnamon
Cinnamon burmannii administered orally as 500-mg capsules three times a day over 12 weeks
Placebo Comparator: Placebo
Placebo administered orally as capsules three times daily over 12 weeks
Placebo administered orally as capsules three times a day over 12 weeks
- Fasting plasma glucose at 12 weeks [ Time Frame: 12 weeks ]Change from baseline in fasting plasma glucose at 12 weeks
- Fasting plasma glucose at 6 weeks [ Time Frame: 6 weeks ]Change from baseline in fasting plasma glucose at 6 weeks
- 2-hour plasma glucose during OGTT (oral glucose tolerance test) [ Time Frame: 12 weeks ]Change from baseline in plasma glucose obtained 2 hours during OGTT at 12 weeks
- Area under the curve-glucose during OGTT (oral glucose tolerance test) [ Time Frame: 12 weeks ]Change from baseline in area under the curve of plasma glucose during OGTT at 12 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219411
|United States, Massachusetts|
|Joslin Diabetes Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Giulio R Romeo, MD||Joslin Diabetes Center|