A Pilot Study: The Effects of Qigong Therapy on Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Fasting Blood Glucose
研究概览
简要总结
Qigong therapy is a subtle energy-based methodology for preventing and healing diseases that has been practiced with remarkable results in China for about five thousand years. Recently, preliminary studies showed that Qigong exercises improve insulin resistance and glucose metabolism in people with type 2 diabetes. These studies suggest that Qigong therapy might be an effective and valuable complementary modality for treating type 2 diabetes. Type 2 diabetes is a chronic disease marked by abnormally high levels of sugar in the blood. Diabetes is a serious disease, which, if not controlled, can be life threatening.
The purpose of this project is to conduct a randomized, controlled pilot clinical trial to compare the effectiveness of Qigong therapy to mild exercise and conventional treatment in type 2 diabetes and to identify biological and psychological characteristics associated with subjects' responses to Qigong therapy.
Aim 1: To compare the effects on blood sugar and hemoglobin A1c (HbA1c) level between a Qigong therapy group and non-treated control group as well as between Qigong group and a progressive resistance training (PRT) group before, during and after and 12-week intervention.
Hypothesis 1: Both Qigong therapy and PRT will help type 2 diabetic patients reduce blood sugar levels to different degrees through improving insulin resistance. But the levels of reduction of blood sugar will be greater by Qigong therapy than by PRT due to enhanced insulin secretion.
Aim 2: To compare the effects on fasting C-peptide and insulin levels between a Qigong therapy group, a PRT group and a non-treated control group before and after the intervention.
Hypothesis 2: Qigong therapy will increase the endogenous insulin and C-peptide levels by restoring the functions of the pancreas, while PRT will not alter either insulin or C-peptide levels.
Aim 3: To compare the effects of Qigong therapy and PRT on blood cortisol levels and psychological stress levels before, during and after the intervention.
Hypothesis 3: Perceived stress and depression will be improved by Qigong therapy to a greater extent than by PRT, and blood cortisol levels will be reduced to a greater extent with Qigong therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes defined as a glycohemoglobin between 7.5% and 10.5%, and fasting insulin level <40 (IU/ml).
- •Must be controlling their diabetes with diet or may be taking oral medication for at least three months
- •Age 18-65
- •Ability to physically perform Qigong or low-intensity physical exercise
- •Body Mass Index 18-40
- •Have current primary care
- •Willing to monitor blood glucose at least twice a day
- •Willing to maintain a consistent diet during the study, and
- •Sign informed consent
排除标准
- •Significant kidney, liver or heart disease
- •History of drug or alcohol abuse within the past 2 years
- •Current or previous use of insulin
- •Use of dietary supplements that affect blood glucose or insulin
- •Current practice of Qigong (any style)
结局指标
主要结局
Fasting Blood Glucose
时间窗: Week 0 (baseline) and week 12 (final)
次要结局
- HOMA-IR Index(weeks 0 and 12)
- Fasting Cortisol(Weeks 0 and 12)
- Beck's Depression Inventory (BDI)(weeks 0 and 12)
- Fasting C-peptide(weeks 0 and 12)
- Fasting Insulin(weeks 0 and 12)
- Perceived Stress Scale (PSS)(weeks 0 and 12)