Clinical trial NCT00885846: Effects of Qigong on Type 2 Diabetic Patients
Official title: A Pilot Study: The Effects of Qigong Therapy on Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Qigong
Breathing management
Glucose
Lead sponsor: Bastyr University
Sponsor class: OTHER
Collaborators: name: Seattle Foundation
First posted: 2009-04-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Fasting Blood Glucose
timeFrame: Week 0 (baseline) and week 12 (final)
Secondary outcomes:
measure: Fasting C-peptide
timeFrame: weeks 0 and 12
measure: Fasting Insulin
timeFrame: weeks 0 and 12
measure: Perceived Stress Scale (PSS)
timeFrame: weeks 0 and 12
measure: Beck's Depression Inventory (BDI)
timeFrame: weeks 0 and 12
measure: HOMA-IR Index
timeFrame: weeks 0 and 12
measure: Fasting Cortisol
timeFrame: Weeks 0 and 12
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Bastyr University Research Center
state: Washington
Study officials:
affiliation: Bastyr University
name: Guan-Cheng Sun, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bastyr University
name: Jennifer C Lovejoy, PhD
role: STUDY_DIRECTOR
affiliation: Bastyr University
name: Ryan Bradley, ND
role: STUDY_CHAIR
References:
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. doi: 10.2337/diacare.25.1.241. No abstract available.
citation: 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.
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. doi: 10.1089/acm.2006.6052.
citation: 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.