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Effects of Qigong on Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Collaborator:
Seattle Foundation
Information provided by:
Bastyr University
ClinicalTrials.gov Identifier:
NCT00885846
First received: February 5, 2009
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Other: Qigong therapy
Other: Progressive resistance training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study: The Effects of Qigong Therapy on Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Bastyr University:

Primary Outcome Measures:
  • Fasting Blood Glucose [ Time Frame: Week 0 (baseline) and week 12 (final) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting C-Peptide [ Time Frame: weeks 0 and 12 ] [ Designated as safety issue: No ]
  • Fasting Insulin [ Time Frame: weeks 0 and 12 ] [ Designated as safety issue: No ]
  • Perceived Stress Scale (PSS) [ Time Frame: weeks 0 and 12 ] [ Designated as safety issue: No ]
  • Beck's Depression Inventory (BDI) [ Time Frame: weeks 0 and 12 ] [ Designated as safety issue: No ]
  • HOMA-IR Index [ Time Frame: weeks 0 and 12 ] [ Designated as safety issue: No ]
  • Fasting Cortisol [ Time Frame: Weeks 0 and 12 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: June 2007
Study Completion Date: May 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885846

Locations
United States, Washington
Bastyr University Research Center
Kenmore, Washington, United States, 98028-4966
Sponsors and Collaborators
Bastyr University
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guan-Cheng Sun, PhD, Bastyr University
ClinicalTrials.gov Identifier: NCT00885846     History of Changes
Other Study ID Numbers: H77B11
Study First Received: February 5, 2009
Results First Received: February 5, 2009
Last Updated: April 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Bastyr University:
Qigong
Breathing management
Glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014