Clinical trial NCT03869411: Effects of Exercise Intervention and Confounding Factors on Type II Diabetic Muscles
Official title: Effects of Exercise Intervention and Confounding Factors on Type II Diabetic Muscles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes and Healthy Control
FTO Gene Expression
Aerobic Exercise Intervention or Home Exercise
Pre-training and Post-training
Keywords: diabetes
muscle quality
aerobic exercise
FTO gene
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: index of muscle stiffness
timeFrame: Change from Baseline muscle quality at 3 months
measure: muscle strength of knee extensor and plantarflexor
timeFrame: Change from Baseline functional performance at 3 months
measure: Relative sliding of muscles
timeFrame: Change from Baseline muscle quality at 3 months
measure: muscle microcirculation
timeFrame: Change from Baseline muscle quality at 3 months
measure: maximum rate of oxygen consumption
timeFrame: Baseline
Secondary outcomes:
measure: characteristics of specific FTO genes
timeFrame: Baseline
measure: physical activity level
timeFrame: Change from Baseline functional performance at 3 months
measure: BMI
timeFrame: Change from Baseline functional performance at 3 months
measure: blood glucose level
timeFrame: Change from Baseline functional performance at 3 months
measure: blood cholesterol
timeFrame: Change from Baseline functional performance at 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
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 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.
citation: 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.
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/dc13-2358. Epub 2014 Mar 4.