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

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ClinicalTrials.gov Identifier: NCT01377558
Recruitment Status : Unknown
Verified April 2011 by University of Giessen.
Recruitment status was:  Active, not recruiting
First Posted : June 21, 2011
Last Update Posted : June 23, 2011
Sponsor:
Collaborator:
Hannover Medical School
Information provided by:
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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Aerobic endurance training intervention Other: Strength endurance training intervention Other: Combined aerobic endurance and strength endurance training Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 -
Study Start Date : April 2011
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : June 2012

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aerobic endurance training intervention
Aerobic endurance training
Other: Aerobic endurance training intervention

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

Other Name: aerobic endurance training
Experimental: Strength endurance training intervention
Strength endurance training
Other: Strength endurance training intervention

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

Other Name: Strength endurance training
Experimental: Combined training intervention
Combined aerobic endurance training and strength endurance training intervention
Other: 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
control group



Primary Outcome Measures :
  1. Change in HbA1c-level (haemoglobin A1c) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in HOMA-Index [ Time Frame: 3 and 6 months ]
  2. Change in beta-cell-function [ Time Frame: 3 and 6 months ]
    Measured by OGTT (Oral Glucose Tolerance Test)

  3. Change in fasting plasma glucose levels [ Time Frame: 3 and 6 months ]
  4. Change in total cholesterol levels [ Time Frame: 3 and 6 months ]
  5. Change in HDL-cholesterol levels [ Time Frame: 3 and 6 months ]
  6. Change in LDL-cholesterol levels [ Time Frame: 3 and 6 months ]
  7. Change in triglyceride levels [ Time Frame: 3 and 6 months ]
  8. Change in antidiabetic medications [ Time Frame: 3 and 6 months ]
    Class and dosage of blood-glucose lowering drugs are recorded before, after 3 and 6 months

  9. Change in inflammation markers [ Time Frame: 3 and 6 months ]
    CrP, blood count, interleukinstatus, cytokinstatus

  10. Change in body weight [ Time Frame: 3 and 6 months ]
  11. Change in body composition [ Time Frame: 3 and 6 months ]
    by Bio-impedance analysis, waist to hip ratio, range of thigh

  12. Change in strength [ Time Frame: 3 and 6 months ]
    by Dr. Wolff Back Check

  13. Change of maximum heart rate [ Time Frame: 3 and 6 months ]
    Measured by an incremental exercise test

  14. Change of peak oxygen uptake [ Time Frame: 3 and 6 months ]
    Measured by an incremental exercise test

  15. Change of vAT (ventilatory anaerobic threshold) [ Time Frame: 3 and 6 months ]
    Measured by an incremental exercise test

  16. Change in blood pressure [ Time Frame: 3 and 6 months ]
  17. Change in renal function [ Time Frame: 3 and 6 months ]
    Creatininlevel, Albuminlevel (urine), Telomere length

  18. Change in concentration [ Time Frame: 3 and 6 months ]
    by d2-test

  19. Change in quality of life [ Time Frame: 3 and 6 months ]
    by questionnaire: SF-12, EQ5

  20. Change of nutrition [ Time Frame: 3 and 6 months ]
    by questionnaire: FEV, FFQ

  21. Change in voluntary physical activity [ Time Frame: 3 and 6 months ]
    meassured by pedometer (one week)

  22. Change of cardiac output by Impedance cardiography [ Time Frame: 3 and 6 months ]
    by Task Force Monitor

  23. Change of barorezeptorsensitivity [ Time Frame: 3 and 6 months ]
    by Task Force Monitor

  24. Change in carotid-Intima-Media-Thickness [ Time Frame: 3 and 6 months ]
  25. Change in aortic pulse-wave velocity [ Time Frame: 3 and 6 months ]
  26. Change in central aortic pressure [ Time Frame: 3 and 6 month ]
  27. Change in endothelial dysfunction [ Time Frame: 3 and 6 months ]
  28. Change of parodontitis [ Time Frame: 3 and 6 months ]
  29. Follow up of all parameters mentioned above [ Time Frame: after 12 months ]
    Follow up after 12 months (6 months after completing the exercise intervention) without any supervised intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377558


Locations
Germany
University of Giessen
Giessen, Hessen, Germany, 35394
Sportpark Zwickau, Glauchau, Meerane
Zwickau, Sachsen, Germany, 08056
Sponsors and Collaborators
University of Giessen
Hannover Medical School
Investigators
Principal Investigator: Andree Hillebrecht, Dr. med. University of Giessen

Responsible Party: Andree Hillebrecht, Dr. med., Department of Sports Medicine Giessen
ClinicalTrials.gov Identifier: NCT01377558     History of Changes
Other Study ID Numbers: Gi-03-2011
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: April 2011

Keywords provided by University of Giessen:
aerobic training
resistance training
combination of aerobic and resistance training
diabetes
type 2 diabetes
HbA1c
endothelial dysfunction
inflammation markers
Parodontitis
Exercise intervention
training

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases