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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03869411
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Actual Duration (Months): 11.5
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes and Healthy Control; FTO Gene Expression; Aerobic Exercise Intervention or Home Exercise; Pre-training and Post-training	Behavioral: supervised aerobic exercise or home-based aerobic exercise	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Effects of Exercise Intervention and Confounding Factors on Type II Diabetic Muscles
• Actual Study Start Date: Aug 15, 2019
• Actual Primary Completion Date: May 31, 2020
• Actual Study Completion Date: Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
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; 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.
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; 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.
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; 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.

Outcome Measures

Primary Outcome Measures

1. index of muscle stiffness [Change from Baseline muscle quality at 3 months]

   elastography was used, units on kPa

2. muscle strength of knee extensor and plantarflexor [Change from Baseline functional performance at 3 months]

   Dynamometer was used to measure muscle strength, units on kilograms

3. Relative sliding of muscles [Change from Baseline muscle quality at 3 months]

   B mode sonography was used, units on mm/s

4. muscle microcirculation [Change from Baseline muscle quality at 3 months]

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

5. maximum rate of oxygen consumption [Baseline]

   Bruce treadmill protocol was used in the maximal exercise testing, maximum rate of oxygen consumption record as ml/kg/min

Secondary Outcome Measures

1. characteristics of specific FTO genes [Baseline]

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

2. physical activity level [Change from Baseline functional performance at 3 months]

   self report the ability of walking one-fourth of a mile, record as degree of difficulty: none, some difficulty, much difficulty, inability

3. BMI [Change from Baseline functional performance at 3 months]

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

4. blood glucose level [Change from Baseline functional performance at 3 months]

   Hemoglobin A1c (HbA1c), unit on percentage

5. blood cholesterol [Change from Baseline functional performance at 3 months]

   total cholesterol, units on mg/dL

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT03869411
• Other Study ID Numbers: 201812135RINB
• First Posted: Mar 11, 2019
• Last Update Posted: Dec 23, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Taiwan University Hospital: diabetes; muscle quality; aerobic exercise; FTO gene

Study Results

No Results Posted as of Dec 23, 2020