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

Type 2 Diabetes Clinical Trial

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 -

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01377558
• Other study ID #: Gi-03-2011
• Status: Active, not recruiting
• Phase: N/A
• First received: June 9, 2011
• Last updated: June 22, 2011
• Start date: April 2011
• Est. completion date: June 2012

Study information

• Verified date: April 2011
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Germany	University of Giessen	Giessen	Hessen
Germany	Sportpark Zwickau, Glauchau, Meerane	Zwickau	Sachsen

Sponsors (2)

Lead Sponsor	Collaborator
University of Giessen	Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

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