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CompletedNCT03869411Updated Dec 23, 2020

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

An interventional study of supervised aerobic exercise or home-based aerobic exercise in Diabetes and Healthy Control, FTO Gene Expression and Aerobic Exercise Intervention or Home Exercise, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-23.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • diabetes
  • muscle quality
  • aerobic exercise
  • FTO gene
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    aerobic exercise group

    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

  • Experimental
    home exercise group

    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

  • Active comparator
    health control group

    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

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.

06

What researchers measure

Primary outcomes

  1. index of muscle stiffness

    elastography was used, units on kPa

    Time frame: Change from Baseline muscle quality at 3 months

  2. muscle strength of knee extensor and plantarflexor

    Dynamometer was used to measure muscle strength, units on kilograms

    Time frame: Change from Baseline functional performance at 3 months

  3. Relative sliding of muscles

    B mode sonography was used, units on mm/s

    Time frame: Change from Baseline muscle quality at 3 months

  4. muscle microcirculation

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

    Time frame: Change from Baseline muscle quality at 3 months

  5. 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

    Time frame: Baseline

Secondary outcomes

  1. characteristics of specific FTO genes

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

    Time frame: Baseline

  2. 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

    Time frame: Change from Baseline functional performance at 3 months

  3. BMI

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

    Time frame: Change from Baseline functional performance at 3 months

  4. blood glucose level

    Hemoglobin A1c (HbA1c), unit on percentage

    Time frame: Change from Baseline functional performance at 3 months

  5. blood cholesterol

    total cholesterol, units on mg/dL

    Time frame: Change from Baseline functional performance at 3 months

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
08

References and documents

Publications

  • Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement executive summary. Diabetes Care. 2010 Dec;33(12):2692-6. doi: 10.2337/dc10-1548. No abstract available. PubMed 21115771 ↗
  • Bacchi E, Negri C, Zanolin ME, Milanese C, Faccioli N, Trombetta M, Zoppini G, Cevese A, Bonadonna RC, Schena F, Bonora E, Lanza M, Moghetti P. Metabolic effects of aerobic training and resistance training in type 2 diabetic subjects: a randomized controlled trial (the RAED2 study). Diabetes Care. 2012 Apr;35(4):676-82. doi: 10.2337/dc11-1655. Epub 2012 Feb 16. PubMed 22344613 ↗
  • Prior SJ, Blumenthal JB, Katzel LI, Goldberg AP, Ryan AS. Increased skeletal muscle capillarization after aerobic exercise training and weight loss improves insulin sensitivity in adults with IGT. Diabetes Care. 2014 May;37(5):1469-75. doi: 10.2337/dc13-2358. Epub 2014 Mar 4. PubMed 24595633 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03869411
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Mar 11, 2019
Start date
Aug 15, 2019
Primary completion
May 31, 2020
Completion
Jul 31, 2020
Last update
Dec 23, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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