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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Aerobic endurance training intervention
Strength endurance training intervention
Combined aerobic endurance and strength endurance training
Sponsored by
University of Giessen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring aerobic training, resistance training, combination of aerobic and resistance training, diabetes, type 2 diabetes, HbA1c, endothelial dysfunction, inflammation markers, Parodontitis, Exercise intervention, training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Giessen
  • Sportpark Zwickau, Glauchau, Meerane

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Aerobic endurance training intervention

Strength endurance training intervention

Combined training intervention

Control group

Arm Description

Aerobic endurance training

Strength endurance training

Combined aerobic endurance training and strength endurance training intervention

control group

Outcomes

Primary Outcome Measures

Change in HbA1c-level (haemoglobin A1c)

Secondary Outcome Measures

Change in HOMA-Index
Change in beta-cell-function
Measured by OGTT (Oral Glucose Tolerance Test)
Change in fasting plasma glucose levels
Change in total cholesterol levels
Change in HDL-cholesterol levels
Change in LDL-cholesterol levels
Change in triglyceride levels
Change in antidiabetic medications
Class and dosage of blood-glucose lowering drugs are recorded before, after 3 and 6 months
Change in inflammation markers
CrP, blood count, interleukinstatus, cytokinstatus
Change in body weight
Change in body composition
by Bio-impedance analysis, waist to hip ratio, range of thigh
Change in strength
by Dr. Wolff Back Check
Change of maximum heart rate
Measured by an incremental exercise test
Change of peak oxygen uptake
Measured by an incremental exercise test
Change of vAT (ventilatory anaerobic threshold)
Measured by an incremental exercise test
Change in blood pressure
Change in renal function
Creatininlevel, Albuminlevel (urine), Telomere length
Change in concentration
by d2-test
Change in quality of life
by questionnaire: SF-12, EQ5
Change of nutrition
by questionnaire: FEV, FFQ
Change in voluntary physical activity
meassured by pedometer (one week)
Change of cardiac output by Impedance cardiography
by Task Force Monitor
Change of barorezeptorsensitivity
by Task Force Monitor
Change in carotid-Intima-Media-Thickness
Change in aortic pulse-wave velocity
Change in central aortic pressure
Change in endothelial dysfunction
Change of parodontitis
Follow up of all parameters mentioned above
Follow up after 12 months (6 months after completing the exercise intervention) without any supervised intervention

Full Information

First Posted
June 9, 2011
Last Updated
June 22, 2011
Sponsor
University of Giessen
Collaborators
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01377558
Brief Title
Effects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes
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 Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Giessen
Collaborators
Hannover Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
aerobic training, resistance training, combination of aerobic and resistance training, diabetes, type 2 diabetes, HbA1c, endothelial dysfunction, inflammation markers, Parodontitis, Exercise intervention, training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic endurance training intervention
Arm Type
Experimental
Arm Description
Aerobic endurance training
Arm Title
Strength endurance training intervention
Arm Type
Experimental
Arm Description
Strength endurance training
Arm Title
Combined training intervention
Arm Type
Experimental
Arm Description
Combined aerobic endurance training and strength endurance training intervention
Arm Title
Control group
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Other
Intervention Name(s)
Aerobic endurance training intervention
Other Intervention Name(s)
aerobic endurance training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Strength endurance training intervention
Other Intervention Name(s)
Strength endurance training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Combined aerobic endurance and strength endurance training
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in HbA1c-level (haemoglobin A1c)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in HOMA-Index
Time Frame
3 and 6 months
Title
Change in beta-cell-function
Description
Measured by OGTT (Oral Glucose Tolerance Test)
Time Frame
3 and 6 months
Title
Change in fasting plasma glucose levels
Time Frame
3 and 6 months
Title
Change in total cholesterol levels
Time Frame
3 and 6 months
Title
Change in HDL-cholesterol levels
Time Frame
3 and 6 months
Title
Change in LDL-cholesterol levels
Time Frame
3 and 6 months
Title
Change in triglyceride levels
Time Frame
3 and 6 months
Title
Change in antidiabetic medications
Description
Class and dosage of blood-glucose lowering drugs are recorded before, after 3 and 6 months
Time Frame
3 and 6 months
Title
Change in inflammation markers
Description
CrP, blood count, interleukinstatus, cytokinstatus
Time Frame
3 and 6 months
Title
Change in body weight
Time Frame
3 and 6 months
Title
Change in body composition
Description
by Bio-impedance analysis, waist to hip ratio, range of thigh
Time Frame
3 and 6 months
Title
Change in strength
Description
by Dr. Wolff Back Check
Time Frame
3 and 6 months
Title
Change of maximum heart rate
Description
Measured by an incremental exercise test
Time Frame
3 and 6 months
Title
Change of peak oxygen uptake
Description
Measured by an incremental exercise test
Time Frame
3 and 6 months
Title
Change of vAT (ventilatory anaerobic threshold)
Description
Measured by an incremental exercise test
Time Frame
3 and 6 months
Title
Change in blood pressure
Time Frame
3 and 6 months
Title
Change in renal function
Description
Creatininlevel, Albuminlevel (urine), Telomere length
Time Frame
3 and 6 months
Title
Change in concentration
Description
by d2-test
Time Frame
3 and 6 months
Title
Change in quality of life
Description
by questionnaire: SF-12, EQ5
Time Frame
3 and 6 months
Title
Change of nutrition
Description
by questionnaire: FEV, FFQ
Time Frame
3 and 6 months
Title
Change in voluntary physical activity
Description
meassured by pedometer (one week)
Time Frame
3 and 6 months
Title
Change of cardiac output by Impedance cardiography
Description
by Task Force Monitor
Time Frame
3 and 6 months
Title
Change of barorezeptorsensitivity
Description
by Task Force Monitor
Time Frame
3 and 6 months
Title
Change in carotid-Intima-Media-Thickness
Time Frame
3 and 6 months
Title
Change in aortic pulse-wave velocity
Time Frame
3 and 6 months
Title
Change in central aortic pressure
Time Frame
3 and 6 month
Title
Change in endothelial dysfunction
Time Frame
3 and 6 months
Title
Change of parodontitis
Time Frame
3 and 6 months
Title
Follow up of all parameters mentioned above
Description
Follow up after 12 months (6 months after completing the exercise intervention) without any supervised intervention
Time Frame
after 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andree Hillebrecht, Dr. med.
Organizational Affiliation
University of Giessen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Giessen
City
Giessen
State/Province
Hessen
ZIP/Postal Code
35394
Country
Germany
Facility Name
Sportpark Zwickau, Glauchau, Meerane
City
Zwickau
State/Province
Sachsen
ZIP/Postal Code
08056
Country
Germany

12. IPD Sharing Statement

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

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