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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03869411
Enrollment
60
Registered
2019-03-11
Start date
2019-08-15
Completion date
2020-07-31
Last updated
2020-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

diabetes, muscle quality, aerobic exercise, FTO gene

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.

Interventions

BEHAVIORALsupervised aerobic exercise or home-based aerobic exercise

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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
maximum rate of oxygen consumptionBaselineBruce treadmill protocol was used in the maximal exercise testing, maximum rate of oxygen consumption record as ml/kg/min
index of muscle stiffnessChange from Baseline muscle quality at 3 monthselastography was used, units on kPa
muscle strength of knee extensor and plantarflexorChange from Baseline functional performance at 3 monthsDynamometer was used to measure muscle strength, units on kilograms
Relative sliding of musclesChange from Baseline muscle quality at 3 monthsB mode sonography was used, units on mm/s
muscle microcirculationChange from Baseline muscle quality at 3 monthsNear-infrared spectroscopy was used to measure oxygen saturation on muscle, units on percentage

Secondary

MeasureTime frameDescription
characteristics of specific FTO genesBaseliners9939609 SNP analysis, record as TT or TA or AA type
physical activity levelChange from Baseline functional performance at 3 monthsself report the ability of walking one-fourth of a mile, record as degree of difficulty: none, some difficulty, much difficulty, inability
BMIChange from Baseline functional performance at 3 monthsweight and height will be combined to report BMI in kg/m\^2
blood glucose levelChange from Baseline functional performance at 3 monthsHemoglobin A1c (HbA1c), unit on percentage
blood cholesterolChange from Baseline functional performance at 3 monthstotal cholesterol, units on mg/dL

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026