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

Aerobic Exercise Intervention or Home Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03869411
• Other study ID #: 201812135RINB
• Status: Completed
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: December 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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 control — View Citation

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 t — View Citation

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/dc13-2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	index of muscle stiffness	elastography was used, units on kPa	Change from Baseline muscle quality at 3 months
Primary	muscle strength of knee extensor and plantarflexor	Dynamometer was used to measure muscle strength, units on kilograms	Change from Baseline functional performance at 3 months
Primary	Relative sliding of muscles	B mode sonography was used, units on mm/s	Change from Baseline muscle quality at 3 months
Primary	muscle microcirculation	Near-infrared spectroscopy was used to measure oxygen saturation on muscle, units on percentage	Change from Baseline muscle quality at 3 months
Primary	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	Baseline
Secondary	characteristics of specific FTO genes	rs9939609 SNP analysis, record as TT or TA or AA type	Baseline
Secondary	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	Change from Baseline functional performance at 3 months
Secondary	BMI	weight and height will be combined to report BMI in kg/m^2	Change from Baseline functional performance at 3 months
Secondary	blood glucose level	Hemoglobin A1c (HbA1c), unit on percentage	Change from Baseline functional performance at 3 months
Secondary	blood cholesterol	total cholesterol, units on mg/dL	Change from Baseline functional performance at 3 months