Diabetes and Osteopathic Manipulative Medicine: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Fasting glucose
研究概览
简要总结
Our research team is proposing a study to investigate the effects of osteopathic manipulative treatment on the blood sugar levels of persons with Type 2 diabetes. The goal of this study is to determine if osteopathic manipulative treatment (OMT) can improve the blood sugar levels of individuals with Type 2 diabetes. Half of the participants will receive osteopathic manipulative treatment (OMT) and the other will receive OMT-sham treatment.
详细描述
The Research Plan
Aims Type II diabetes is a common endocrine disorder of glucose metabolism that is linked to considerable morbidity and mortality. In the United States, diabetes is a major cause of cardiovascular disorders including heart disease and stroke. It continues to rise in prevalence despite the advances made in methods of diabetic glucose control. Diabetes is a complex chronic disease that involves continuous medical care and self-management strategies. The main treatment strategies consist of medications and lifestyle modifications. However, the strategies used in clinical trials while effective are impractical as they are intensive and expensive to ensure maintaining these treatment strategies over time. A major opportunity exists for treatment modalities that are affordable and readily implementable such as OMT.
Osteopathic literature suggests that there may be a role for OMT in the treatment of patients with diabetes mellitus. This is supported by our preliminary data reported below. The OMT protocol developed for this research study is based on osteopathic literature and geared towards optimizing bodily function for patients with Type II diabetes and blood-glucose homeostasis. OMT utilizes manual forces directed to improve physiological function and homeostasis by reducing localized dysfunctions of the body referred to as somatic dysfunctions. OMT may be beneficial in reducing blood glucose levels in Type 2 diabetic individuals. Improving glucose levels in type II diabetics would reduce the morbidities and complications of this disorder and have a large impact on patients' health outcomes as well as in healthcare systems worldwide.
Specific Aims: To determine if the OMT protocol outlined in this study will improve glucose and A1C levels in individuals with Type II diabetes.
- To investigate whether the use of OMM (osteopathic manipulative medicine) targeting pancreatic function will decrease blood glucose in diabetic patients after each OMM treatment (short-term effects)
- To investigate whether the use of OMM targeting pancreatic function over a 3 month period will decrease blood glucose in diabetic patients (long-term effects)
- To investigate whether the use of OMM targeting pancreatic function over a 3 month period will decrease A1C levels in diabetic patients (long-term effects)
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcomes assessor will be blinded to the arm the participants have been randomly assigned
入排标准
- 年龄范围
- 30 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Type II diabetes
- •Able to provide consent for participation
- •Currently taking only oral diabetic medication(s)
- •Prior hemoglobin A1C test result
- •Able to fast for the glucose measurements
- •Able to complete the intake and consent documents
排除标准
- •Insulin dependent diabetes
- •Unable or unwilling to provide informed consent
- •Unable to fast for the glucose measurements
- •Have an absolute contraindication to OMT (i.e. Acute fracture, joint dislocation, an open wound or infection)
- •Pregnant women
结局指标
主要结局
Fasting glucose
时间窗: 3 months
Short term fasting glucose levels
次要结局
- A1C(3 months)
