Diabetes Mellitus, Type 2NCT00885846

Effects of Qigong on Type 2 Diabetic Patients

A study testing Qigong therapy and Progressive resistance training in people with Diabetes Mellitus, Type 2, run by Bastyr University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Qigong therapy and Progressive resistance training
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: Jun 2007to May 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

Willing to monitor blood glucose at least twice a day
Willing to maintain a consistent diet during the study, and
Sign informed consent

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Bastyr University Research Center
Kenmore, Washington, 98028-4966

Other trials in United States

About this study

Official title: 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.

Conditions: Diabetes Mellitus, Type 2
Being tested: Qigong therapy, Progressive resistance training
Keywords: Qigong, Breathing management, Glucose
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Qigong therapyOther
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 trainingOther
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.

Study groups in NCT00885846
Study group	Role	What they receive
Qigong Therapy	Active comparator	Not described Receives: Other: Qigong therapy
PRT	Active comparator	Not described Receives: Other: Progressive resistance training
Control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Fasting Blood Glucose
Measured: Week 0 (baseline) and week 12 (final)

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007May 2008

First posted22 Apr 2009 (estimated)
Study startJun 2007
Primary completionJan 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00885846
Sponsor's protocol ID: H77B11
Status last verified: Apr 2015
First submitted: 5 Feb 2009
Last updated: 16 Nov 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 11772923
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.
PubMed 10471015
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.
PubMed 17532735
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.
PubMed 20040671

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study: The Effects of Qigong Therapy on Type 2 Diabetic Patients
ClinicalTrials.gov ID: NCT00885846
Acronym / sponsor ID: H77B11
Conditions: Diabetes Mellitus, Type 2
Keywords: Qigong, Breathing management, Glucose
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Bastyr UniversityUniversity, hospital or other
Collaborators: Seattle Foundation
Study start: Jun 2007
Primary completion: Jan 2008 (actual)
Study completion: May 2008 (actual)
First posted: 22 Apr 2009 (estimated)
Results: Posted 22 Apr 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Qigong Therapy	Active comparator	Other: Qigong therapy
PRT	Active comparator	Other: Progressive resistance training
Control	No intervention	–

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Qigong therapyFor 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.	Other	Qigong Therapy
Progressive resistance trainingFor 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.	Other	PRT

Primary outcome

Fasting Blood Glucose
Time frame: Week 0 (baseline) and week 12 (final)

6 secondary outcomes

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

Results and safety

Results posted to the registry on 22 Apr 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Qigong Therapy	11	9
Progressive Resistance Training (PRT)	11	6
Non-treated Control	10	8

Primary outcome: Fasting Blood Glucose

Time frame: Week 0 (baseline) and week 12 (final). Mean (Standard Deviation). Unit: mg/dL

Measure	Qigong Therapy n = 7	Progressive Resistance Training (PRT) n = 5	Non-treated Control n = 8
week 0 (baseline)	184.9 (35.3)	143.8 (35.0)	156.4 (36.6)
week 12 (final)	161.9 (40.5)	154.0 (44.7)	168.4 (49.1)

Qigong Therapy vs Progressive Resistance Training (PRT) vs Non-treated Control: p = 0.664, Repeated ANOVA

Population analysed: Analysis performed per protocol. Participants excluded from analysis for changing or discontinuing medication during intervention.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Qigong Therapy	0 of 11 (0%)	0 of 11 (0%)	Not reported
Progressive Resistance Training	0 of 11 (0%)	0 of 11 (0%)	Not reported
Control	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11772923Tsujiuchi 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.
Background: PubMed 10471015Iwao 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.
Background: PubMed 17532735Xin 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.
Derived from this study: PubMed 20040671Sun 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Guan-Cheng Sun, PhD principal investigator

Bastyr University

Jennifer C Lovejoy, PhD study director

Bastyr University

Ryan Bradley, ND study chair

Bastyr University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Qigong therapy and Progressive resistance training in people with Diabetes Mellitus, Type 2, run by Bastyr University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Blood Glucose (time frame: Week 0 (baseline) and week 12 (final)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00885846, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.