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Type 2 DiabetesNCT01377558

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

A study testing Aerobic endurance training intervention, Strength endurance training intervention and Combined aerobic endurance and strength endurance training in people with Type 2 Diabetes, run by University of Giessen at 2 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Aerobic endurance training intervention, Strength endurance training intervention and Combined aerobic endurance and strength endurance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesGermany
Study dates
Apr 2011to Jun 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnoses of type 2 diabetes (ADA criteria)
  • admitted diabetes treatments will be diet and oral hypoglycemic agents

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • University of Giessen

    Giessen, Hesse, 35394

  • Sportpark Zwickau, Glauchau, Meerane

    Zwickau, Saxony, 08056

Other trials in Germany

About this study

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 -

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
Read the 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.

Conditions
Type 2 Diabetes
Being tested
Aerobic endurance training intervention, Strength endurance training intervention, Combined aerobic endurance and strength endurance training
Keywords
aerobic training, resistance training, combination of aerobic and resistance training, diabetes, type 2 diabetes, HbA1c, endothelial dysfunction, inflammation markers, Parodontitis, Exercise intervention, training
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Dry Socket

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic endurance training interventionOther

    Also called aerobic endurance training

    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 interventionOther

    Also called Strength endurance training

    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 trainingOther

    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

Study groups in NCT01377558
Study groupRoleWhat they receive
Aerobic endurance training interventionExperimentalAerobic endurance training
Receives: Other: Aerobic endurance training intervention
Strength endurance training interventionExperimentalStrength endurance training
Receives: Other: Strength endurance training intervention
Combined training interventionExperimentalCombined aerobic endurance training and strength endurance training intervention
Receives: Other: Combined aerobic endurance and strength endurance training
Control groupNo interventioncontrol group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c-level (haemoglobin A1c)

    Measured: 6 months

Secondary outcomes (29)

  1. Change in HOMA-Index

    Measured: 3 and 6 months

  2. Change in beta-cell-function

    Measured by OGTT (Oral Glucose Tolerance Test)

    Measured: 3 and 6 months

  3. Change in fasting plasma glucose levels

    Measured: 3 and 6 months

  4. Change in total cholesterol levels

    Measured: 3 and 6 months

  5. Change in HDL-cholesterol levels

    Measured: 3 and 6 months

  6. Change in LDL-cholesterol levels

    Measured: 3 and 6 months

  7. Change in triglyceride levels

    Measured: 3 and 6 months

  8. Change in antidiabetic medications

    Class and dosage of blood-glucose lowering drugs are recorded before, after 3 and 6 months

    Measured: 3 and 6 months

  9. Change in inflammation markers

    CrP, blood count, interleukinstatus, cytokinstatus

    Measured: 3 and 6 months

  10. Change in body weight

    Measured: 3 and 6 months

  11. Change in body composition

    by Bio-impedance analysis, waist to hip ratio, range of thigh

    Measured: 3 and 6 months

  12. Change in strength

    by Dr. Wolff Back Check

    Measured: 3 and 6 months

  13. Change of maximum heart rate

    Measured by an incremental exercise test

    Measured: 3 and 6 months

  14. Change of peak oxygen uptake

    Measured by an incremental exercise test

    Measured: 3 and 6 months

  15. Change of vAT (ventilatory anaerobic threshold)

    Measured by an incremental exercise test

    Measured: 3 and 6 months

  16. Change in blood pressure

    Measured: 3 and 6 months

  17. Change in renal function

    Creatininlevel, Albuminlevel (urine), Telomere length

    Measured: 3 and 6 months

  18. Change in concentration

    by d2-test

    Measured: 3 and 6 months

  19. Change in quality of life

    by questionnaire: SF-12, EQ5

    Measured: 3 and 6 months

  20. Change of nutrition

    by questionnaire: FEV, FFQ

    Measured: 3 and 6 months

  21. Change in voluntary physical activity

    meassured by pedometer (one week)

    Measured: 3 and 6 months

  22. Change of cardiac output by Impedance cardiography

    by Task Force Monitor

    Measured: 3 and 6 months

  23. Change of barorezeptorsensitivity

    by Task Force Monitor

    Measured: 3 and 6 months

  24. Change in carotid-Intima-Media-Thickness

    Measured: 3 and 6 months

  25. Change in aortic pulse-wave velocity

    Measured: 3 and 6 months

  26. Change in central aortic pressure

    Measured: 3 and 6 month

  27. Change in endothelial dysfunction

    Measured: 3 and 6 months

  28. Change of parodontitis

    Measured: 3 and 6 months

  29. Follow up of all parameters mentioned above

    Follow up after 12 months (6 months after completing the exercise intervention) without any supervised intervention

    Measured: after 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionNov 2011 (estimated)
  4. Study completionJun 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01377558
Sponsor's protocol ID
Gi-03-2011
Status last verified
Apr 2011
First submitted
9 Jun 2011
Last updated
23 Jun 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic endurance training intervention, Strength endurance training intervention and Combined aerobic endurance and strength endurance training in people with Type 2 Diabetes, run by University of Giessen at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c-level (haemoglobin A1c) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01377558.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.

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