Clinical trial NCT01377558: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Hannover Medical School
First posted: 2011-06-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in HbA1c-level (haemoglobin A1c)
timeFrame: 6 months
Secondary outcomes:
measure: Change in HOMA-Index
timeFrame: 3 and 6 months
measure: Change in beta-cell-function
timeFrame: 3 and 6 months
measure: Change in fasting plasma glucose levels
timeFrame: 3 and 6 months
measure: Change in total cholesterol levels
timeFrame: 3 and 6 months
measure: Change in HDL-cholesterol levels
timeFrame: 3 and 6 months
measure: Change in LDL-cholesterol levels
timeFrame: 3 and 6 months
measure: Change in triglyceride levels
timeFrame: 3 and 6 months
measure: Change in antidiabetic medications
timeFrame: 3 and 6 months
measure: Change in inflammation markers
timeFrame: 3 and 6 months
measure: Change in body weight
timeFrame: 3 and 6 months
measure: Change in body composition
timeFrame: 3 and 6 months
measure: Change in strength
timeFrame: 3 and 6 months
measure: Change of maximum heart rate
timeFrame: 3 and 6 months
measure: Change of peak oxygen uptake
timeFrame: 3 and 6 months
measure: Change of vAT (ventilatory anaerobic threshold)
timeFrame: 3 and 6 months
measure: Change in blood pressure
timeFrame: 3 and 6 months
measure: Change in renal function
timeFrame: 3 and 6 months
measure: Change in concentration
timeFrame: 3 and 6 months
measure: Change in quality of life
timeFrame: 3 and 6 months
measure: Change of nutrition
timeFrame: 3 and 6 months
measure: Change in voluntary physical activity
timeFrame: 3 and 6 months
measure: Change of cardiac output by Impedance cardiography
timeFrame: 3 and 6 months
measure: Change of barorezeptorsensitivity
timeFrame: 3 and 6 months
measure: Change in carotid-Intima-Media-Thickness
timeFrame: 3 and 6 months
measure: Change in aortic pulse-wave velocity
timeFrame: 3 and 6 months
measure: Change in central aortic pressure
timeFrame: 3 and 6 month
measure: Change in endothelial dysfunction
timeFrame: 3 and 6 months
measure: Change of parodontitis
timeFrame: 3 and 6 months
measure: Follow up of all parameters mentioned above
timeFrame: after 12 months
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: University of Giessen
state: Hessen
city: Zwickau
country: Germany
facility: Sportpark Zwickau, Glauchau, Meerane
state: Sachsen
Study officials:
affiliation: University of Giessen
name: Andree Hillebrecht, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: