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Completed

NCT Number: NCT03869411

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

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.

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Key information

Conditions

Diabetes and Healthy Control Aerobic Exercise Intervention or Home Exercise Diabetes Mellitus Endocrine System Diseases FTO Gene Expression Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pre-training and Post-training

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

supervised aerobic exercise or home-based aerobic exercise

Behavioral

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.

Primary outcomes

  1. index of muscle stiffness

    Time frame: Change from Baseline muscle quality at 3 months

    elastography was used, units on kPa

  2. muscle strength of knee extensor and plantarflexor

    Time frame: Change from Baseline functional performance at 3 months

    Dynamometer was used to measure muscle strength, units on kilograms

  3. Relative sliding of muscles

    Time frame: Change from Baseline muscle quality at 3 months

    B mode sonography was used, units on mm/s

  4. muscle microcirculation

    Time frame: Change from Baseline muscle quality at 3 months

    Near-infrared spectroscopy was used to measure oxygen saturation on muscle, units on percentage

  5. maximum rate of oxygen consumption

    Time frame: Baseline

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

Secondary outcomes

  1. characteristics of specific FTO genes

    Time frame: Baseline

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

  2. physical activity level

    Time frame: 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

  3. BMI

    Time frame: Change from Baseline functional performance at 3 months

    weight and height will be combined to report BMI in kg/m^2

  4. blood glucose level

    Time frame: Change from Baseline functional performance at 3 months

    Hemoglobin A1c (HbA1c), unit on percentage

  5. blood cholesterol

    Time frame: Change from Baseline functional performance at 3 months

    total cholesterol, units on mg/dL

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 11, 2019
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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