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Clinical Trials/NCT01377558
NCT01377558
Unknown
Not Applicable

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 -

University of Giessen2 sites in 1 country100 target enrollmentStarted: April 2011Last updated:
ConditionsType 2 Diabetes

Overview

Phase
Not Applicable
Enrollment
100
Locations
2
Primary Endpoint
Change in HbA1c-level (haemoglobin A1c)

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in HbA1c-level (haemoglobin A1c)

Time Frame: 6 months

Secondary Outcomes

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

Investigators

Sponsor Class
Other

Study Sites (2)

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