Effects of Exercise Intervention and Confounding Factors on Type II Diabetic Muscles
- Conditions
- Aerobic Exercise Intervention or Home ExerciseFTO Gene ExpressionDiabetes and Healthy ControlPre-training and Post-training
- Interventions
- Behavioral: supervised aerobic exercise or home-based aerobic exercise
- Registration Number
- NCT03869411
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
The aim of the first year of this three-year plan is to analyze and compare the muscle quality of lower limb muscle (microcirculation, muscle performance and mechanical characteristics) and maximal aerobic exercise capacity in treadmill exercise tests for diabetic and non-diabetic cases. The hypotheses are:1) the muscle quality of lower limb muscle and maximal aerobic exercise capacity are different between participate with diabetic and non-diabetic, 2) the effect of the three-month aerobic exercise intervention or home exercise on the characteristics of the muscle quality are different , and 3) intrinsic factors (such as age, BMI, and HDL) and characteristics of specific FTO genes are influenced the training outcomes.
- Detailed Description
Participants with diabetes will attend an 12-week aerobic exercise intervention or home exercise if the exercise test result of the maximum rate of oxygen consumption is fair or poor. Assessments will be taken before and after the training program, which including muscle strength, stiffness, quality, microcirculation and exercise capacity. Comparisons between the pre-training and post-training condition will be made for each groups. And the assessments also compare with the healthy control group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Diabetes group: 1) Age between 30-70 years of old, 2) type 2 diabetes.
- Healthy control group: 1) Age between 30-70 years of old, 2) without diabetes
- history of moderate-severe somatic or autonomic neuropathy, cardiovascular disease, preproliferative or proliferative retinopathy, and chronic renal failure
- unable to perform the programs or assessments
- other systematic diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description health control group supervised aerobic exercise or home-based aerobic exercise This study will recruit subjects without type 2 diabetes and the age matched to the diabetes groups. aerobic exercise group supervised aerobic exercise or home-based aerobic exercise This study will recruit qualified diabetic subjects according to their results of maximal aerobic exercise capacity (VO2max) and assign them into aerobic exercise or home exercise groups, based on their willingness. The aerobic exercise group will arranged to the supervised aerobic dance program, it's consisted of 50 mins per session, 3 sessions per week and last for 3 months. home exercise group supervised aerobic exercise or home-based aerobic exercise This study will recruit qualified diabetic subjects according to their results of maximal aerobic exercise capacity (VO2max) and assign them into aerobic exercise or home exercise groups, based on their willingness.The home exercise group will give the exercise recommendation based on ACSM's guideline, and it's consisted of 50 mins per session, 3 sessions per week and last for 3 months.
- Primary Outcome Measures
Name Time Method index of muscle stiffness Change from Baseline muscle quality at 3 months elastography was used, units on kPa
muscle microcirculation Change from Baseline muscle quality at 3 months Near-infrared spectroscopy was used to measure oxygen saturation on muscle, units on percentage
muscle strength of knee extensor and plantarflexor Change from Baseline functional performance at 3 months Dynamometer was used to measure muscle strength, units on kilograms
maximum rate of oxygen consumption Baseline Bruce treadmill protocol was used in the maximal exercise testing, maximum rate of oxygen consumption record as ml/kg/min
Relative sliding of muscles Change from Baseline muscle quality at 3 months B mode sonography was used, units on mm/s
- Secondary Outcome Measures
Name Time Method physical activity level Change from Baseline functional performance at 3 months self report the ability of walking one-fourth of a mile, record as degree of difficulty: none, some difficulty, much difficulty, inability
blood cholesterol Change from Baseline functional performance at 3 months total cholesterol, units on mg/dL
characteristics of specific FTO genes Baseline rs9939609 SNP analysis, record as TT or TA or AA type
blood glucose level Change from Baseline functional performance at 3 months Hemoglobin A1c (HbA1c), unit on percentage
BMI Change from Baseline functional performance at 3 months weight and height will be combined to report BMI in kg/m\^2
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan