Effects of Qigong on Type 2 Diabetic Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885846
• Other study ID #: H77B11
• Status: Completed
• Phase: N/A
• First received: February 5, 2009
• Last updated: October 23, 2015
• Start date: June 2007
• Est. completion date: May 2008

Study information

• Verified date: April 2015
• Source: Bastyr University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Bastyr University Research Center	Kenmore	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Bastyr University	Seattle Foundation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Blood Glucose		Week 0 (baseline) and week 12 (final)	No
Secondary	Fasting C-peptide		weeks 0 and 12	No
Secondary	Fasting Insulin		weeks 0 and 12	No
Secondary	Perceived Stress Scale (PSS)		weeks 0 and 12	No
Secondary	Beck's Depression Inventory (BDI)		weeks 0 and 12	No
Secondary	HOMA-IR Index		weeks 0 and 12	No
Secondary	Fasting Cortisol		Weeks 0 and 12	No