Effects of Qigong on Type 2 Diabetic Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study: The Effects of Qigong Therapy on Type 2 Diabetic Patients

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Qigong therapy
* Other: Progressive resistance training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Qigong Therapy<br> | Other: Qigong therapy<br>* For 12 weeks, subjects in Qigong therapy group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.<br>|
| Active Comparator: PRT<br> | Other: Progressive resistance training<br>* For 12 weeks, subjects in the PRT group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Blood Glucose |  | Week 0 (baseline) and week 12 (final) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting C-peptide |  | weeks 0 and 12 | 
| Fasting Insulin |  | weeks 0 and 12 | 
| Perceived Stress Scale (PSS) |  | weeks 0 and 12 | 
| Beck's Depression Inventory (BDI) |  | weeks 0 and 12 | 
| HOMA-IR Index |  | weeks 0 and 12 | 
| Fasting Cortisol |  | Weeks 0 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Qigong, Breathing management, Glucose