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临床试验/NCT03663322
NCT03663322Unknown不适用

Diabetes and Osteopathic Manipulative Medicine: A Randomized Controlled Trial

New York Institute of Technology4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月15日最近更新:
适应症

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.

  1. 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)
  2. 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)
  3. 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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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