A Multi-National, Double-Blind, Randomized Trial Of The Influence Of Cinnamon Powders In Subjects With Risk For Developing Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Fasting plasma glucose at 12 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo administered orally as capsules three times daily over 12 weeks
干预措施: placebo (Other)
Cinnamon
Cinnamon burmannii administered orally as 500-mg capsules three times daily over 12 weeks
干预措施: Cinnamon (Dietary Supplement)
结局指标
主要结局
Fasting plasma glucose at 12 weeks
时间窗: 12 weeks
Change from baseline in fasting plasma glucose at 12 weeks
次要结局
- 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)