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Effects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes

Not Applicable
Conditions
Type 2 Diabetes
Interventions
Other: Aerobic endurance training intervention
Other: Strength endurance training intervention
Other: Combined aerobic endurance and strength endurance training
Registration Number
NCT01377558
Lead Sponsor
University of Giessen
Brief Summary

The purposes of the study are

* to determine which kind of supervised exercise intervention (aerobic endurance training versus strength endurance training versus combined aerobic endurance and strength endurance training) is more effective in improving the metabolic parameters in typ 2 diabetes patients

* to investigate what kind of intervention is more successful in reduction of concomitant diseases and improving quality of life

* to assess what kind of intervention induces highest effects in long term persistence of these positive changes

Detailed Description

Meta-analyses which evaluated the effects of structured exercise programs in patients with type 2 diabetes demonstrate that regular physical activity improves glycosylated haemoglobin (König et al.: Resistance Exercise and Type 2 Diabetes Mellitus, Deutsche Zeitschrift für Sportmedizin Jahrgang 62, Nr. 1 (2011): 5-9). Sigal et al. proved that either aerobic or resistance training alone improved glycemic control in type 2 diabetes, but the improvements are greatest with combined aerobic and resistance training (Sigal, RJ, et al.: Effects of Aerobic Training, Resistance Training, or Both on Glycemic Control in Type 2 Diabetes, Ann Intern Med. 2007 Sep 18;147(6):357-69).

Therefore, aim of the current study is to compare the effects of aerobic endurance training or resistance endurance training or the combination of aerobic endurance training and resistance endurance training in diabetes type 2 patients without any other lifestyle or dietary interventions.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
Inclusion Criteria
  • diagnoses of type 2 diabetes (ADA criteria)
  • admitted diabetes treatments will be diet and oral hypoglycemic agents
Exclusion Criteria
  • sports intervention >60 minutes per week
  • medical conditions
  • preproliferative or proliferative retinopathy
  • instable coronary heart disease
  • inability to perform the scheduled physical activity programs
  • acute clinically significant intercurrent diseases

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Aerobic endurance training interventionAerobic endurance training interventionAerobic endurance training
Strength endurance training interventionStrength endurance training interventionStrength endurance training
Combined training interventionCombined aerobic endurance and strength endurance trainingCombined aerobic endurance training and strength endurance training intervention
Primary Outcome Measures
NameTimeMethod
Change in HbA1c-level (haemoglobin A1c)6 months
Secondary Outcome Measures
NameTimeMethod
Change in HOMA-Index3 and 6 months
Change in beta-cell-function3 and 6 months

Measured by OGTT (Oral Glucose Tolerance Test)

Change in fasting plasma glucose levels3 and 6 months
Change in total cholesterol levels3 and 6 months
Change in HDL-cholesterol levels3 and 6 months
Change in LDL-cholesterol levels3 and 6 months
Change in triglyceride levels3 and 6 months
Change in antidiabetic medications3 and 6 months

Class and dosage of blood-glucose lowering drugs are recorded before, after 3 and 6 months

Change in inflammation markers3 and 6 months

CrP, blood count, interleukinstatus, cytokinstatus

Change in body weight3 and 6 months
Change in body composition3 and 6 months

by Bio-impedance analysis, waist to hip ratio, range of thigh

Change in strength3 and 6 months

by Dr. Wolff Back Check

Change of maximum heart rate3 and 6 months

Measured by an incremental exercise test

Change of peak oxygen uptake3 and 6 months

Measured by an incremental exercise test

Change of vAT (ventilatory anaerobic threshold)3 and 6 months

Measured by an incremental exercise test

Change in blood pressure3 and 6 months
Change in renal function3 and 6 months

Creatininlevel, Albuminlevel (urine), Telomere length

Change in concentration3 and 6 months

by d2-test

Change in quality of life3 and 6 months

by questionnaire: SF-12, EQ5

Change of nutrition3 and 6 months

by questionnaire: FEV, FFQ

Change in voluntary physical activity3 and 6 months

meassured by pedometer (one week)

Change of cardiac output by Impedance cardiography3 and 6 months

by Task Force Monitor

Change of barorezeptorsensitivity3 and 6 months

by Task Force Monitor

Change in carotid-Intima-Media-Thickness3 and 6 months
Change in aortic pulse-wave velocity3 and 6 months
Change in central aortic pressure3 and 6 month
Change in endothelial dysfunction3 and 6 months
Change of parodontitis3 and 6 months
Follow up of all parameters mentioned aboveafter 12 months

Follow up after 12 months (6 months after completing the exercise intervention) without any supervised intervention

Trial Locations

Locations (2)

Sportpark Zwickau, Glauchau, Meerane

🇩🇪

Zwickau, Sachsen, Germany

University of Giessen

🇩🇪

Giessen, Hessen, Germany

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