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

NCT ID: NCT03869411

Last Updated: 2020-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-15

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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diabetes muscle quality aerobic exercise FTO gene

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

supervised aerobic exercise or home-based aerobic exercise

Intervention Type 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.

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.

Group Type EXPERIMENTAL

supervised aerobic exercise or home-based aerobic exercise

Intervention Type 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.

health control group

This study will recruit subjects without type 2 diabetes and the age matched to the diabetes groups.

Group Type ACTIVE_COMPARATOR

supervised aerobic exercise or home-based aerobic exercise

Intervention Type 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.

Interventions

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supervised 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 21115771 (View on PubMed)

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.

Reference Type RESULT
PMID: 22344613 (View on PubMed)

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.

Reference Type RESULT
PMID: 24595633 (View on PubMed)

Other Identifiers

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201812135RINB

Identifier Type: -

Identifier Source: org_study_id