Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Seattle Foundation | OTHER |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qigong Therapy | Active Comparator |
| |
| PRT | Active Comparator |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Glucose | Week 0 (baseline) and week 12 (final) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting C-peptide | weeks 0 and 12 | |
| Fasting Insulin | weeks 0 and 12 | |
| Perceived Stress Scale (PSS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guan-Cheng Sun, PhD | Bastyr University | Principal Investigator |
| Jennifer C Lovejoy, PhD | Bastyr University | Study Director |
| Ryan Bradley, ND | Bastyr University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bastyr University Research Center | Kenmore | Washington | 98028-4966 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11772923 | Background | 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. | |
| 10471015 | Background |
Not provided
Not provided
The second cohort was necessary to achieve desired sample size.
Participant recruitment for cohort 1: August 2007. Participant recruitment for cohort 2: February 2008. Place of recruitment: Bastyr University Research Institute.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Qigong Therapy | Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks. |
| FG001 | Progressive Resistance Training (PRT) | Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks. |
| FG002 | Non-treated Control | Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Qigong Therapy | Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks. |
| BG001 | Progressive Resistance Training (PRT) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Fasting C-peptide | Not Posted | weeks 0 and 12 | |||||||||||||
| Secondary | Fasting Insulin | Not Posted | weeks 0 and 12 | |||||||||||||
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Qigong Therapy | 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. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guan-Cheng Sun, PhD | Bastyr University | 425-602-3389 | gsun@bastyr.edu |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| weeks 0 and 12 |
| Beck's Depression Inventory (BDI) | weeks 0 and 12 |
| HOMA-IR Index | weeks 0 and 12 |
| Fasting Cortisol | Weeks 0 and 12 |
| 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. |
| 17532735 | 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. |
| 20040671 | Derived | 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. |
Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
| BG002 | Non-treated Control | Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks). |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Perceived Stress Scale (PSS) |
| Not Posted |
| weeks 0 and 12 |
| Secondary | Beck's Depression Inventory (BDI) | Not Posted | weeks 0 and 12 |
| Secondary | HOMA-IR Index | Not Posted | weeks 0 and 12 |
| Secondary | Fasting Cortisol | Not Posted | Weeks 0 and 12 |
| Primary | Fasting Blood Glucose | Analysis performed per protocol. Participants excluded from analysis for changing or discontinuing medication during intervention. | Posted | Mean | Standard Deviation | mg/dL | Week 0 (baseline) and week 12 (final) |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Progressive Resistance Training | 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. | 0 | 11 | 0 | 11 |
| EG002 | Control | Wait list group; no activity at this arm. On list to start Qigong | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
|