Effects of Qigong on Type 2 Diabetic Patients

NCT00885846 | Completed Results

• 1 other identifier: H77B11
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Qigong; Breathing management; Glucose

Outcome Measures

Primary Outcomes (1)

• Fasting Blood Glucose

  Week 0 (baseline) and week 12 (final)

Secondary Outcomes (6)

• 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

Study Arms (3)

Qigong Therapy

ACTIVE COMPARATOR

Other: Qigong therapy

PRT

ACTIVE COMPARATOR

Other: Progressive resistance training

Control

NO INTERVENTION

Interventions

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.

Qigong Therapy

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.

PRT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bastyr University: lead
• Seattle Foundation: collaborator

Study Sites (1)

Bastyr University Research Center

Kenmore, Washington, 98028-4966, United States

Location

Related Publications (4)

• Tsujiuchi T, Kumano H, Yoshiuchi K, He D, Tsujiuchi Y, Kuboki T, Suematsu H, Hirao K. The effect of Qi-gong relaxation exercise on the control of type 2 diabetes mellitus: a randomized controlled trial. Diabetes Care. 2002 Jan;25(1):241-2. doi: 10.2337/diacare.25.1.241. No abstract available.

  PMID: 11772923 BACKGROUND

• Iwao M, Kajiyama S, Mori H, Oogaki K. Effects of qigong walking on diabetic patients: a pilot study. J Altern Complement Med. 1999 Aug;5(4):353-8. doi: 10.1089/acm.1999.5.353.

  PMID: 10471015 BACKGROUND

• Xin L, Miller YD, Brown WJ. A qualitative review of the role of qigong in the management of diabetes. J Altern Complement Med. 2007 May;13(4):427-33. doi: 10.1089/acm.2006.6052.

  PMID: 17532735 BACKGROUND

• Sun GC, Lovejoy JC, Gillham S, Putiri A, Sasagawa M, Bradley R. Effects of Qigong on glucose control in type 2 diabetes: a randomized controlled pilot study. Diabetes Care. 2010 Jan;33(1):e8. doi: 10.2337/dc09-1543. No abstract available.

  PMID: 20040671 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Limitations to this study include high withdrawal rate from PRT group, especially during the first cohort. Also, participants from both Qigong and PRT group changed or discontinued medications. Consequently, their results were excluded from analysis.

Results Point of Contact

• Title: Guan-Cheng Sun, PhD
• Organization: Bastyr University

gsun@bastyr.edu

425-602-3389

Study Officials

• Guan-Cheng Sun, PhD

  Bastyr University

  PRINCIPAL INVESTIGATOR

• Jennifer C Lovejoy, PhD

  Bastyr University

  STUDY DIRECTOR

• Ryan Bradley, ND

  Bastyr University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: April 22, 2009
• Study Start: June 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: May 1, 2008
• Last Updated: November 16, 2015
• Results First Posted: April 22, 2009

Record last verified: 2015-04

Locations

US (1)