Secondary Prevention in Type 2 Diabetes: Comparison of Two Different Resistance Exercise Training Protocols

Study Overview
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Brief Summary
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Skeletal muscle accounts for up to 40% of the total body weight and is responsible for approximately 75% of the whole body insulin-stimulated glucose uptake. Resistance training has been shown to improve insulin-stimulated glucose uptake in patients with T2DM. Therefore the investigators aim to compose the effects of 2 different resistance training protocols in combination with aerobic endurance training (AET) on muscle strength, muscle mass and glycemic control in type 2 diabetes mellitus patients (T2DM). The investigators aim to perform an 8 week randomized controlled training intervention in 32 T2DM patients. Patients will be randomly assigned to AET (cycle ergometer, 60-70% of heart rate reserve) combined with hypertrophy resistance training (HRT, n=16, 2 sets, 10-12 repetitions, 70% of the one-repetition maximum) or with endurance resistance training (ERT, n=16, 2 sets, 25-30 repetitions, 40% of the one-repetition maximum). Body composition, blood analyses, physical work capacity and muscle strength will be measured pre- and post-intervention.

Official Title
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Combined Resistance and Endurance Training in Patients With Type 2 Diabetes: A Pilot-study to Assess the Effects of 2 Different Resistance Protocols on Muscle Mass, Strength and Glycemic Control.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Physical exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes mellitus Exclusion Criteria: myocardial infarction within the last 6 months unstable angina pectoris left ventricular ejection fraction less than 40% orthopedic limitations that eliminate to perform resistance training

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypertrophy resistance training<br>Aerobic endurance training combined with hypertrophy resistance training in type 2 diabetes mellitus. | Other: Physical exercise training<br>* aerobic endurance training (cycle ergometer, 60-70% heart rate reserve) hypertrophy resistance training (2sets, 10-12 repetitions, 70% of the one-repetition maximum) endurance resistance training (2 sets, 25-30 repetitions, 40% of the one-repetition maximum)<br>* Other names: resistance training;|
| Active Comparator: Endurance resistance training<br>Aerobic endurance training combined with hypertrophy resistance training in type 2 diabetes mellitus. | Other: Physical exercise training<br>* aerobic endurance training (cycle ergometer, 60-70% heart rate reserve) hypertrophy resistance training (2sets, 10-12 repetitions, 70% of the one-repetition maximum) endurance resistance training (2 sets, 25-30 repetitions, 40% of the one-repetition maximum)<br>* Other names: resistance training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Measruement will be performed using Concept Dyno 2 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass | Muscle mass will be measured using dual X-ray absorbiotometry | 8 weeks | 
| Glycemic control | Fasting blood glucose, HbA1c, and fructosamin will be measured using routine laboratory methods | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, type 2 diabetes, T2DM, resistance training, hypertrophy training, endurance training