Tai Chi Quan Improving Biochemistry and Quality of Life in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Tai Chi Quan Improving Blood Glucose, Blood Lipid, and Quality of Life in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03562078
• Other study ID #: TaipeiCityH
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: September 2018

Study information

• Verified date: June 2018
• Source: Taipei City Hospital
• Contact: Chien-Jung Huang, Bachelor
• Phone: (+886)2-2591-6681
• Email: DAI62[@]tpech.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the hypothesis that the 12-week Tai Chi Quan training would have better control of blood sugar, biochemistry profile, and also better quality of life and activity of autonomic nerve system (ANS). The subjects were randomize assigned to either Tai Chi group or control group. The outcome measures before and after 12-week intervention include basic demographic characteristics, HbA1c, fasting blood glucose(FBG), triglycerides (TG), high and low density lipoprotein (HDL, LDL), creatinine(Cr), eGFR, GPT, ACR, quality of life, and activity of automatic nerve system.

Description:

In this study, the hypothesis that the 12-week Tai Chi Quan training would have better control of blood sugar, biochemistry index, and also better quality of life and activity of automatic nerve system. In the study, type 2 diabetes mellitus(T2DM) patients will be recruited as subjects. The subjects were randomized to either Tai Chi group or control group. Tai Chi group would take Tai Chi Quan training for 1hr, twice a week for 12 weeks. There were 10-minute warm-up, 40-minute Tai Chi lesson, and 10-minute cool-down exercise in the training. In this study, the 1st section of Yang style 108 form is chosen for the experiment group. Both group were given diabetic patients care education and the exercise recording book for encouraging the daily exercise habits. The outcome measures before and after 12-week intervention include basic demographic characteristics, HbA1c, fasting blood glucose, triglycerides, high and low density lipid, creatinine, eGFR, GPT, ACR, quality of life, and activity of automatic nerve system.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 40~80 years old

• Diagnosed type 2 diabetes mellitus, and without changing dietary pattern and medical treatment for blood glucose or blood lipid.

• Consciousness clear and is voluntary to attend the project and with the agreement.

• The functional movement ability is independent

Exclusion Criteria:

• Pregnant or plan to be pregnant in six months, and breast feeding.

• Severe complication in six months such as myocardial infarction, stroke, severe traumatic injury, major surgery. Other diseases evaluated by the doctor that are not suitable for the project.

• Evaluated that the compliance for the intervention is not appropriate.

• The blood glucose > 300mg/dl and unable to do vigorous exercise.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Tai Chi Quan
the first section of Yang style 108 form, including 10-minute warm-up, 40-minute training, and 10-minute cool-down exercise, twice a week

Locations

Country	Name	City	State
Taiwan	Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei City Hospital	National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin	HbA1c	change from Baseline to 12 weeks
Secondary	fasting blood glucose	blood sample after 8-hour fasting	change from Baseline to 12 weeks
Secondary	triglycerides	blood sample after 8-hour fasting	change from Baseline to 12 weeks
Secondary	high and low density lipoprotein	blood sample after 8-hour fasting	change from Baseline to 12 weeks
Secondary	creatinine	blood sample after 8-hour fasting	change from Baseline to 12 weeks
Secondary	estimated Glomerular Filtration Rate (eGFR)	blood sample after 8-hour fasting	change from Baseline to 12 weeks
Secondary	Glutamic-Pyruvic Transaminase (GPT)	blood sample after 8-hour fasting	change from Baseline to 12 weeks
Secondary	urine albumin/creatinine ratio (ACR)	from urine sample	change from Baseline to 12 weeks
Secondary	quality of life	WHOQOL-BREF Taiwan	change from Baseline to 12 weeks
Secondary	heart rate variability	represent for balance of autonomic nervous system	change from Baseline to 12 weeks
Secondary	low frequency (LF)	Low frequency is the frequency domain analysis from heart rate variability, and is represent for sympathetic nervous system	change from Baseline to 12 weeks
Secondary	high frequency (HF)	High frequency is the frequency domain analysis from heart rate variability, and is represent for parasympathetic nervous system	change from Baseline to 12 weeks