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Diabetes and Healthy ControlNCT03869411

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

A study testing supervised aerobic exercise or home-based aerobic exercise in people with Diabetes and Healthy Control and FTO Gene Expression, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 70 yearsHealthy volunteers can take part
What is being tested?
supervised aerobic exercise or home-based aerobic exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
15 Aug 2019to 31 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

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.

Being tested
supervised aerobic exercise or home-based aerobic exercise
Keywords
diabetes, muscle quality, aerobic exercise, FTO gene
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • supervised aerobic exercise or home-based aerobic exerciseBehavioural

    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.

Study groups in NCT03869411
Study groupRoleWhat they receive
aerobic exercise groupExperimentalThis 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.
Receives: Behavioral: supervised aerobic exercise or home-based aerobic exercise
home exercise groupExperimentalThis 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.
Receives: Behavioral: supervised aerobic exercise or home-based aerobic exercise
health control groupActive comparatorThis study will recruit subjects without type 2 diabetes and the age matched to the diabetes groups.
Receives: Behavioral: supervised aerobic exercise or home-based aerobic exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. index of muscle stiffness

    elastography was used, units on kPa

    Measured: 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

    Measured: Change from Baseline functional performance at 3 months

  3. Relative sliding of muscles

    B mode sonography was used, units on mm/s

    Measured: 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

    Measured: 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

    Measured: Baseline

Secondary outcomes (5)

  1. characteristics of specific FTO genes

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

    Measured: 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

    Measured: Change from Baseline functional performance at 3 months

  3. BMI

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

    Measured: Change from Baseline functional performance at 3 months

  4. blood glucose level

    Hemoglobin A1c (HbA1c), unit on percentage

    Measured: Change from Baseline functional performance at 3 months

  5. blood cholesterol

    total cholesterol, units on mg/dL

    Measured: Change from Baseline functional performance at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2019
  2. Study start15 Aug 2019
  3. Primary completion31 May 2020
  4. Study completion31 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03869411
Sponsor's protocol ID
201812135RINB
Status last verified
Dec 2020
First submitted
5 Mar 2019
Last updated
23 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing supervised aerobic exercise or home-based aerobic exercise in people with Diabetes and Healthy Control and FTO Gene Expression, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

index of muscle stiffness (time frame: Change from Baseline muscle quality at 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03869411, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.

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