Trial document




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  DRKS00004160

Trial Description

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Title

Improving glucose metabolism beyond the effects of bariatric surgery by standardized postoperative exercise programs

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Trial Acronym

GluMBSE Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Therapeutic options for morbidly obese patients comprise lifestyle changes, medication, and physical activity. In some patients operative procedures such as gastric bypass are used for weight reduction. It is still unclear whether physical activity additionally supports the improvement of glucose metabolism in these patients. In clinical studies it has been shown, that resistance training influences glucose metabolism in type 2 diabetes patients more effectively than specific endurance training. Therefore, this study aims at comparing the effects of a standardized resistance training with endurance training (each twice a week for 60 min) in a period of 6 months after bariatric surgery on glucose metabolism, fat-free mass and resting energy expenditure.

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Brief Summary in Scientific Language

In this prospective, randomized, controlled trial the effects of supervised exercise vs. normal activity will be compared. Furthermore the differences between resistance and endurance training after laparascopic Roux-en-Y gastric bypass surgery in morbidly obese patients with regard to the improvement of glucose metabolism, insulin sensitivity and resting energy expenditure will be analyzed.

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Organizational Data

  •   DRKS00004160
  •   2012/05/31
  •   [---]*
  •   yes
  •   Approved
  •   363-11-07032011, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   U1111-1131-0765 
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Health Condition or Problem studied

  •   E66.82 -  [generalization E66.8: Other obesity]
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Interventions/Observational Groups

  •   Resistance training for 6 months after bariatric surgery: 2 times a week 60 min
  •   Endurance training training for 6 months after bariatric surgery: 2 times a week 60 min
  •   Control: normal activity and general exercise suggestion for 6 months after bariatric surgery
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

2h OGTT (oral glucose tolerance test) plasma glucose preoperatively as well as 1, 3, and 6 months after bariatric surgery

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Secondary Outcome

Resting energy expenditure (REE) by indirect calorimetry preoperatively as well as 1, 3, and 6 months after bariatric surgery

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/08/07
  •   140
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

- BMI > 40 kg/m² or BMI > 35 kg/m² plus obesity associated comorbidities and BMI < 60 kg/m²;
- Patients undergoing gastric bypass without any complication (including guidelines / indication for bariatric surgery);
- Start of sport program before day 28 postoperatively;
-Written informed consent.

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Exclusion Criteria

- Any chronic inflammatory or malignant disease;
- Type I diabetes;
- Relevant joint or spinal disorders;
- Contraindication for sports therapy;
- Drug or alcohol abuse;
- Untreated thyroid dysfunction;
- Pregnancy or breast feeding woman;
- expected non-compliance
- participation in other interventional trials

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Addresses

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    • Universitätsklinikum Leipzig AöR Klinik u. Poliklinik für Visceral-, Transplantations-, Thorax- u. Gefäßchirurgie
    • Mr.  PD Dr. med.  Arne  Dietrich 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig AöR Klinik u. Poliklinik für Visceral-, Transplantations-, Thorax- u. Gefäßchirurgie
    • Mr.  PD Dr. med.  Arne  Dietrich 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig AöR Klinik u. Poliklinik für Visceral-, Transplantations-, Thorax- u. Gefäßchirurgie
    • Mr.  PD Dr. med.  Arne  Dietrich 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.