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

Not Applicable
Completed
Conditions
Aerobic Exercise Intervention or Home Exercise
FTO Gene Expression
Diabetes and Healthy Control
Pre-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
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
health control groupsupervised aerobic exercise or home-based aerobic exerciseThis study will recruit subjects without type 2 diabetes and the age matched to the diabetes groups.
aerobic exercise groupsupervised aerobic exercise or home-based aerobic exerciseThis 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 groupsupervised aerobic exercise or home-based aerobic exerciseThis 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
NameTimeMethod
index of muscle stiffnessChange from Baseline muscle quality at 3 months

elastography was used, units on kPa

muscle microcirculationChange 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 plantarflexorChange from Baseline functional performance at 3 months

Dynamometer was used to measure muscle strength, units on kilograms

maximum rate of oxygen consumptionBaseline

Bruce treadmill protocol was used in the maximal exercise testing, maximum rate of oxygen consumption record as ml/kg/min

Relative sliding of musclesChange from Baseline muscle quality at 3 months

B mode sonography was used, units on mm/s

Secondary Outcome Measures
NameTimeMethod
physical activity levelChange 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 cholesterolChange from Baseline functional performance at 3 months

total cholesterol, units on mg/dL

characteristics of specific FTO genesBaseline

rs9939609 SNP analysis, record as TT or TA or AA type

blood glucose levelChange from Baseline functional performance at 3 months

Hemoglobin A1c (HbA1c), unit on percentage

BMIChange 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

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