Effects of Qigong on Type 2 Diabetic Patients

October 23, 2015 updated by: Bastyr University

A Pilot Study: The Effects of Qigong Therapy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Kenmore, Washington, United States, 98028-4966
        • Bastyr University Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Qigong Therapy
Other: Qigong therapy
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.
Active Comparator: PRT
Other: Progressive resistance training
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bastyr University

Collaborators

Seattle Foundation

Investigators

  • Principal Investigator: Guan-Cheng Sun, PhD, Bastyr University
  • Study Director: Jennifer C Lovejoy, PhD, Bastyr University
  • Study Chair: Ryan Bradley, ND, Bastyr University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

April 13, 2009

First Posted (Estimate)

April 22, 2009

Study Record Updates

Last Update Posted (Estimate)

November 16, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H77B11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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