The Effect of Cinnamon Cassia on Diabetes Control and Cardiometabolic Risk Factors in Adults With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Type 2 DM control
研究概览
简要总结
The overall goal of this proposal is to establish the efficacy of cinnamon for the treatment of T2DM. Additional aims will assess the effect of cinnamon on cardiovascular risk factors and explore novel potential mechanisms of action leading to improved insulin sensitivity. Based on previously published animal and human data we have hypothesized that six months treatment with Cinnamon cassia supplementation (2.25 grams/day) will improve glycemic control and cardio-metabolic risk factors. We believe these benefits may be mediated in part through improved insulin mediated capillary recruitment and skeletal muscle vasodilators leading to reduced insulin resistance. We will achieve our goal through completion of the following aims:
Aim 1. To demonstrate the efficacy, safety, and tolerability of oral cinnamon use (750 mg three times daily) to improve glucose control. The primary outcome will be determined as a reduction in hemglobin A1c (HbA1c) level of at least 0.5% compared to placebo.
Aim 2. To quantify effects of oral cinnamon (vs. placebo) on cardio-metabolic risk factors, including: fasting levels of plasma insulin and glucose, homeostatic model assessment of insulin resistance (HOMA-IR), lipids (total, VLDL, LDL, HDL cholesterol; triglyceride), free fatty acids, as well whole body, abdominal, and visceral adiposity as measured with dual energy x-ray absorptiometry (DEXA) imaging.
Aim 3. In this mechanistic exploratory aim, potential gastrointesitnal effects will be assessed as follows: a 3-hour oral glucose tolerance test (OGTT) with blood samples collected for insulin, glucose, C-peptide, glucagon, GLP-1, and GIP will be performed separately. Additional biochemical markers (ghrelin, PYY, pro-insulin, apo B, adinopectin) will be collected as well.
详细描述
Experimental Design:
This Phase 2 study will be done prospectively and will be conducted in two stages. The initial stage will be the general study and the second stage will be the sub-study. We plan to screen up to 1,000 subjects. Our enrollment goal is 250 subjects total (with 50 subjects enrolled in the sub-study and 200 subjects enrolled in the general study).
Adults will be screened from Oregon Health & Science University clinics (cardiology, internal medicine, endocrinology, obstetrics and gynecology, family practice) through Epic-based database searches and research flyer distribution. At OHSU, the Research Data Warehouse (RDW) will be used to identify potential subjects and recruitment letters will be sent out. Additional advertisement will be conducted through March Wellness and the medical exercise program. Further outreach advertising will be done through the Oregon Association of Naturopathic Physicians (OANP) website and the Naturopathic Doctor News & Reviews (NDNR) newsletter.
We will not include any vulnerable populations. We will not recruit prisoners, children, neonates, and/or adults lacking capacity.
In the event of a screen failure, the data collected in screening will be retained to avoid future re-contacting for recruitment for this study. The data will be handled in a confidential manner until destroyed at the end of enrollment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ages 30-65 years of age
- •Diagnosed Type 2 diabetes with a HbA1c of 6.5-9%, treated with either lifestyle alone or with metformin
- •Weight stable for 3 months as defined by no greater than a 5% change.
排除标准
- •Pregnancy
- •Breast feeding
- •Use of any other diabetes treatment other than metformin within the past 3 months
- •Type 1 diabetes
- •HbA1c > 9% or less than< 6.5%
- •Liver disease with a known diagnosis of cirrhosis
- •Liver Dysfunction with AST or ALT liver enzymes > 2x upper limit of normal
- •Chronic Kidney Disease with glomerular filtration rate < 45 ml/min/1.73m2
- •Anemia with hematocrit < 30%
- •TSH > 5 or < 0.4 mIU/L
- •Coagulopathy, INR > 1.3
- •Use of warfarin or other new oral anticoagulants (dabigatran, rivaroxaban, apixaban)
- •Use of subcutaneous heparin, enoxaparin, dalteparin
- •Use of class 1 or class 3 anti-arrhythmic medications (disopyramide, procainamide, quinidine, mexilitine, flecanide, propafenone, amiodarone, sotalol, dronedarone, dofetilide)
- •Use of immunosuppressants (methotrexate, prednisone, tacrolimus, sirolimus, azathioprine, mycophenolate, cyclosporine)
- •Chronic use of benzodiazepines (midazolam, alprazolam, lorezepam, temezepam, diazepam, clonazepam, chlordiazepoxide) for the past 3 months
- •Chronic use of medications that may affect body weight, glucose or lipid metabolism (e.g., anti-psychotics, anti-seizure, weight loss meds) for the past 3 months
- •Patients with celiac sprue or gluten sensitive individuals
- •Self-report of > 3 alcoholic drinks per day
- •Congestive heart failure (ejection fraction < 45%)
研究组 & 干预措施
Study Drug
Randomized to cinnamon cassia 750 mg TID for 6 months. Assess HbA1c and CV risk profile
干预措施: Cinnamon (Drug)
Placebo
Randomized to placebo matching tablet TID for 6 months. Assess HbA1c and CV risk profile
干预措施: placebo (Drug)
结局指标
主要结局
Type 2 DM control
时间窗: 6 months
change in HbA1c
次要结局
- lipid control(6 months)
- obesity(6 months)
研究者
Scott M. Chadderdon
Assistant Professor
Oregon Health and Science University