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

• 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.

Study Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Study Start: 2019-08-15
• Primary Completion: 2020-05-31
• Study Completion: 2020-07-31
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-23

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
index of muscle stiffness	Change from Baseline muscle quality at 3 months	elastography was used, units on kPa
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