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

National Taiwan University

Status: Completed

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

Treatments: Behavioral: supervised aerobic exercise or home-based aerobic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03869411

201812135RINB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

aerobic exercise group

Experimental group

Description:

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.

Treatment:

Behavioral: supervised aerobic exercise or home-based aerobic exercise

home exercise group

Experimental group

Description:

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.

Treatment:

Behavioral: supervised aerobic exercise or home-based aerobic exercise

health control group

Active Comparator group

Description:

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

Treatment:

Behavioral: supervised aerobic exercise or home-based aerobic exercise