Effects of Exercise Intervention and Confounding Factors on Type II Diabetic Muscles

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Exercise Intervention and Confounding Factors on Type II Diabetic Muscles

Conditions
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Diabetes and Healthy Control, FTO Gene Expression, Aerobic Exercise Intervention or Home Exercise, Pre-training and Post-training

Intervention / Treatment
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* Behavioral: supervised aerobic exercise or home-based aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: his study is going to recruit subjects with and without type 2 diabetes and age between 30 and 70 years old. This study will be focused on the effects of diabetes on maximum aerobic exercise intensity (VO2max) and muscle quality including microcirculation (by NIRS), mechanical properties (by elastography) and isometric strength in different age groups, and observe whether these results are related to the clinically relevant findings of diabetes. This study will recruit qualified diabetic subjects according to their results of maximal aerobic exercise capacity (VO2max) and assign them into two groups; aerobic exercise or home exercise intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aerobic exercise group<br>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. | Behavioral: supervised aerobic exercise or home-based aerobic exercise<br>* The aerobic exercise and home exercise programs are consisted of 50 minutes per time, 3 times per weeks and totally 3 months. The aerobic exercise group will perform the exercise program under one physical therapy and one aerobic dance teacher supervised. The home exercise group will do the exercise program based on ACSM's aerobic exercise recommend, and will used the home exercise record form to make sure their cooperation.<br>|
| Experimental: home exercise group<br>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. | Behavioral: supervised aerobic exercise or home-based aerobic exercise<br>* The aerobic exercise and home exercise programs are consisted of 50 minutes per time, 3 times per weeks and totally 3 months. The aerobic exercise group will perform the exercise program under one physical therapy and one aerobic dance teacher supervised. The home exercise group will do the exercise program based on ACSM's aerobic exercise recommend, and will used the home exercise record form to make sure their cooperation.<br>|
| Active Comparator: health control group<br>This study will recruit subjects without type 2 diabetes and the age matched to the diabetes groups. | Behavioral: supervised aerobic exercise or home-based aerobic exercise<br>* The aerobic exercise and home exercise programs are consisted of 50 minutes per time, 3 times per weeks and totally 3 months. The aerobic exercise group will perform the exercise program under one physical therapy and one aerobic dance teacher supervised. The home exercise group will do the exercise program based on ACSM's aerobic exercise recommend, and will used the home exercise record form to make sure their cooperation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| index of muscle stiffness | elastography was used, units on kPa | Change from Baseline muscle quality at 3 months | 
| muscle strength of knee extensor and plantarflexor | Dynamometer was used to measure muscle strength, units on kilograms | Change from Baseline functional performance at 3 months | 
| Relative sliding of muscles | B mode sonography was used, units on mm/s | Change from Baseline muscle quality at 3 months | 
| muscle microcirculation | Near-infrared spectroscopy was used to measure oxygen saturation on muscle, units on percentage | Change from Baseline muscle quality at 3 months | 
| maximum rate of oxygen consumption | Bruce treadmill protocol was used in the maximal exercise testing, maximum rate of oxygen consumption record as ml/kg/min | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characteristics of specific FTO genes | rs9939609 SNP analysis, record as TT or TA or AA type | Baseline | 
| physical activity level | self report the ability of walking one-fourth of a mile, record as degree of difficulty: none, some difficulty, much difficulty, inability | Change from Baseline functional performance at 3 months | 
| BMI | weight and height will be combined to report BMI in kg/m^2 | Change from Baseline functional performance at 3 months | 
| blood glucose level | Hemoglobin A1c (HbA1c), unit on percentage | Change from Baseline functional performance at 3 months | 
| blood cholesterol | total cholesterol, units on mg/dL | Change from Baseline functional performance at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, muscle quality, aerobic exercise, FTO gene