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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Giessen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hannover Medical School
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT01377558
First received: June 9, 2011
Last updated: June 22, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes
 Other: Aerobic endurance training intervention
Other: Strength endurance training intervention
Other: Combined aerobic endurance and strength endurance training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 -

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Change in HbA1c-level (haemoglobin A1c) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HOMA-Index [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in beta-cell-function [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Measured by OGTT (Oral Glucose Tolerance Test)

  • Change in fasting plasma glucose levels [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in total cholesterol levels [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in HDL-cholesterol levels [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in LDL-cholesterol levels [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in triglyceride levels [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in antidiabetic medications [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Class and dosage of blood-glucose lowering drugs are recorded before, after 3 and 6 months

  • Change in inflammation markers [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    CrP, blood count, interleukinstatus, cytokinstatus

  • Change in body weight [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in body composition [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    by Bio-impedance analysis, waist to hip ratio, range of thigh

  • Change in strength [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    by Dr. Wolff Back Check

  • Change of maximum heart rate [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Measured by an incremental exercise test

  • Change of peak oxygen uptake [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Measured by an incremental exercise test

  • Change of vAT (ventilatory anaerobic threshold) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Measured by an incremental exercise test

  • Change in blood pressure [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in renal function [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Creatininlevel, Albuminlevel (urine), Telomere length

  • Change in concentration [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    by d2-test

  • Change in quality of life [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    by questionnaire: SF-12, EQ5

  • Change of nutrition [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    by questionnaire: FEV, FFQ

  • Change in voluntary physical activity [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    meassured by pedometer (one week)

  • Change of cardiac output by Impedance cardiography [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    by Task Force Monitor

  • Change of barorezeptorsensitivity [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    by Task Force Monitor

  • Change in carotid-Intima-Media-Thickness [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in aortic pulse-wave velocity [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in central aortic pressure [ Time Frame: 3 and 6 month ] [ Designated as safety issue: No ]
  • Change in endothelial dysfunction [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Change of parodontitis [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Follow up of all parameters mentioned above [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    Follow up after 12 months (6 months after completing the exercise intervention) without any supervised intervention


Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Other Name: Combined aerobic endurance and strength endurance training
No Intervention: Control group
control group

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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. Justus-Liebig University Giessen
  More Information

No publications provided

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
Study First Received: June 9, 2011
Last Updated: June 22, 2011
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 19, 2013