Diabetes Mellitus, Type 2
Conditions
Keywords
Qigong, Breathing management, Glucose
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.
Interventions
OTHERQigong 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.
OTHERProgressive 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.
Sponsors
Seattle Foundation
Bastyr University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose | Week 0 (baseline) and week 12 (final) |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Insulin | weeks 0 and 12 |
| Perceived Stress Scale (PSS) | weeks 0 and 12 |
| Fasting C-peptide | weeks 0 and 12 |
| HOMA-IR Index | weeks 0 and 12 |
| Fasting Cortisol | Weeks 0 and 12 |
| Beck's Depression Inventory (BDI) | weeks 0 and 12 |
Countries
United States
Participant flow
Recruitment details
Participant recruitment for cohort 1: August 2007. Participant recruitment for cohort 2: February 2008. Place of recruitment: Bastyr University Research Institute.
Pre-assignment details
The second cohort was necessary to achieve desired sample size.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 11 |
| Non-treated Control Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks). | 10 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 5 | 2 |
Baseline characteristics
| Characteristic | Progressive Resistance Training (PRT) | Non-treated Control | Qigong Therapy | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 0 Participants | 5.0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 7 Participants | 11 Participants | 27.0 Participants |
| Age, Continuous | 52.8 years STANDARD_DEVIATION 9.9 | 60.2 years STANDARD_DEVIATION 6.3 | 56.2 years STANDARD_DEVIATION 7.5 | 56.3 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment United States | 11 participants | 10 participants | 11 participants | 32.0 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 7 Participants | 19.0 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 4 Participants | 13.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 10 |
Outcome results
Primary
Fasting Blood Glucose
Time frame: Week 0 (baseline) and week 12 (final)
Population: Analysis performed per protocol. Participants excluded from analysis for changing or discontinuing medication during intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Qigong Therapy | Fasting Blood Glucose | week 0 (baseline) | 184.9 mg/dL | Standard Deviation 35.3 |
| Qigong Therapy | Fasting Blood Glucose | week 12 (final) | 161.9 mg/dL | Standard Deviation 40.5 |
| Progressive Resistance Training (PRT) | Fasting Blood Glucose | week 0 (baseline) | 143.8 mg/dL | Standard Deviation 35 |
| Progressive Resistance Training (PRT) | Fasting Blood Glucose | week 12 (final) | 154.0 mg/dL | Standard Deviation 44.7 |
| Non-treated Control | Fasting Blood Glucose | week 0 (baseline) | 156.4 mg/dL | Standard Deviation 36.6 |
| Non-treated Control | Fasting Blood Glucose | week 12 (final) | 168.4 mg/dL | Standard Deviation 49.1 |
Comparison: Power analysis suggested 27 participants, 9 in each group.p-value: 0.664Repeated ANOVA
Secondary
Beck's Depression Inventory (BDI)
Time frame: weeks 0 and 12
Secondary
Fasting Cortisol
Time frame: Weeks 0 and 12
Secondary
Fasting C-peptide
Time frame: weeks 0 and 12
Secondary
Fasting Insulin
Time frame: weeks 0 and 12
Secondary
HOMA-IR Index
Time frame: weeks 0 and 12
Secondary
Perceived Stress Scale (PSS)
Time frame: weeks 0 and 12