Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments aerobic endurance training intervention, strength endurance training intervention, combined aerobic endurance and strength endurance training
Sponsor University of Giessen
Collaborator Hannover Medical School
Start date April 2011
End date November 2011
Trial size 100 participants
Trial identifier NCT01377558, Gi-03-2011

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Aerobic endurance training
aerobic endurance training intervention aerobic endurance training
The aerobic endurance training group will use cardiovascular training devices week 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT two times per week week 5-13: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT two times per week week 14-26: 15 minutes warm up (group) 45 minutes intervention at 95-110% vAT two times per week
(Experimental)
Strength endurance training
strength endurance training intervention Strength endurance training
The strength endurance training intervention group will perform eight exercises on weight machines (Milon circuit training- 60 seconds activity, 30 seconds break) week 1-4: 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) two times per week week 5-13: 15 minutes warm up (group) 2 sessions resistance training intensity 5 (Buskies) two times per week week 14-26: 15 minutes warm up (group) 3 sessions resistance training intensity 5 (Buskies) two times per week
(Experimental)
Combined aerobic endurance training and strength endurance training intervention
combined aerobic endurance and strength endurance training Combined aerobic endurance and strength endurance training
week 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT once per week and 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) once per week week 5-13: 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) two times per week week 14-26: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) once a week and 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 2 sessions resistance training intensity 5 (Buskies) once a week
(No Intervention)
control group

Primary Outcomes

Measure
Change in HbA1c-level (haemoglobin A1c)
time frame: 6 months

Secondary Outcomes

Measure
Change in HOMA-Index
time frame: 3 and 6 months
Change in beta-cell-function
time frame: 3 and 6 months
Change in fasting plasma glucose levels
time frame: 3 and 6 months
Change in total cholesterol levels
time frame: 3 and 6 months
Change in HDL-cholesterol levels
time frame: 3 and 6 months
Change in LDL-cholesterol levels
time frame: 3 and 6 months
Change in triglyceride levels
time frame: 3 and 6 months
Change in antidiabetic medications
time frame: 3 and 6 months
Change in inflammation markers
time frame: 3 and 6 months
Change in body weight
time frame: 3 and 6 months
Change in body composition
time frame: 3 and 6 months
Change in strength
time frame: 3 and 6 months
Change of maximum heart rate
time frame: 3 and 6 months
Change of peak oxygen uptake
time frame: 3 and 6 months
Change of vAT (ventilatory anaerobic threshold)
time frame: 3 and 6 months
Change in blood pressure
time frame: 3 and 6 months
Change in renal function
time frame: 3 and 6 months
Change in concentration
time frame: 3 and 6 months
Change in quality of life
time frame: 3 and 6 months
Change of nutrition
time frame: 3 and 6 months
Change in voluntary physical activity
time frame: 3 and 6 months
Change of cardiac output by Impedance cardiography
time frame: 3 and 6 months
Change of barorezeptorsensitivity
time frame: 3 and 6 months
Change in carotid-Intima-Media-Thickness
time frame: 3 and 6 months
Change in aortic pulse-wave velocity
time frame: 3 and 6 months
Change in central aortic pressure
time frame: 3 and 6 month
Change in endothelial dysfunction
time frame: 3 and 6 months
Change of parodontitis
time frame: 3 and 6 months
Follow up of all parameters mentioned above
time frame: after 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes - Aerobic Endurance Training Versus Strength Endurance Training Versus Combined Aerobic Endurance and Strength Endurance Training -
Principal investigator Andree Hillebrecht, Dr. med.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by University of Giessen.