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NCT Number: NCT00885846

Effects of Qigong on Type 2 Diabetic Patients

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bastyr University Research Center

Kenmore, Washington, 98028-4966, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Qigong therapy

Other

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.

Progressive resistance training

Other

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.

Primary outcomes

  1. Fasting Blood Glucose

    Time frame: Week 0 (baseline) and week 12 (final)

Secondary outcomes

  1. Fasting C-peptide

    Time frame: weeks 0 and 12

  2. Fasting Insulin

    Time frame: weeks 0 and 12

  3. Perceived Stress Scale (PSS)

    Time frame: weeks 0 and 12

  4. Beck's Depression Inventory (BDI)

    Time frame: weeks 0 and 12

  5. HOMA-IR Index

    Time frame: weeks 0 and 12

  6. Fasting Cortisol

    Time frame: Weeks 0 and 12

Sponsors and collaborators

Lead sponsor

Bastyr University

Other

Collaborators

  • Seattle Foundation

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 22, 2009
Registry last updated
Nov 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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