Effects of Qigong on Type 2 Diabetic Patients

NCT ID: NCT00885846

Last Updated: 2015-11-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Qigong Therapy

Group Type ACTIVE_COMPARATOR

Qigong therapy

Intervention Type 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.

PRT

Group Type ACTIVE_COMPARATOR

Progressive resistance training

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seattle Foundation

OTHER

Sponsor Role collaborator

Bastyr University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guan-Cheng Sun, PhD

Role: PRINCIPAL_INVESTIGATOR

Bastyr University

Jennifer C Lovejoy, PhD

Role: STUDY_DIRECTOR

Bastyr University

Ryan Bradley, ND

Role: STUDY_CHAIR

Bastyr University

Locations

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Bastyr University Research Center

Kenmore, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11772923 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10471015 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17532735 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20040671 (View on PubMed)

Other Identifiers

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H77B11

Identifier Type: -

Identifier Source: org_study_id

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