Trial document




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  DRKS00007810

Trial Description

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Title

Metabolic Surgery for Type 2 Diabetes within BMI range of 27 to 60 kg/m²

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Trial Acronym

MetaSurg

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In patients with diabetes (Diabetes mellitus Type 2) blood sugar concentrations are often too high despite blood sugar lowering medication. As a consequence severe co-morbidities might develop. Other treatment options for diabetes are bariatric surgery, mostly gastric bypass operation, in which the stomach is surgically reduced in size and the first part of the small bowel is bypassed.
Aim of this study is to compare the effectiveness of the standard gastric bypass with a gastric bypass where the length of the bypassed small bowel is changed and an obeservational control group with standard medical treatment without bariatric surgery with regard to HbA1c levels after one year.
Patients with diabetes mellitus type 2 are included, who are in the age range of 18 to 60 years and in the BMI range of 27 to 60 kg/m².
During follow-up the following parameters are additionally investigated: Remission rate of diabetes mellitus type 2 after 1 year, weight loss, visceral fat mass and need of medication for other co-morbidities.

Changes in the study protocol, amendment 1 of 28/02/2016 and amendment 2 of 29/06/16, were approved by the ethics commission at Leipzig University Medical Center
on 18/02/16 and on 26/07/16, respectively.

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Brief Summary in Scientific Language

Diabetes mellitus Type 2 is a major burden on public health due to its high prevalence and the association with severe co-morbidities. Good glycaemic control decreases long-term morbidity and mortality. However, HbA1c levels are unsatisfacory for many patients. A certain number of prospective trials demonstrated that bariatric procedures (mostly Roux-en-Y gastric bypass) can lead to remission of Diabetes type 2 in a high percentage of patients.
The MetaSurg Study is an open prospective randomized parallel group trial comparing the short and mid-term effects of standard Roux-en-Y gastric bypass with changed limb length Roux-en-Y gastric bypass and a control arm with standard medical treatment in patients with diabetes mellitus type 2 in a BMI range of 27 to 60 kg/m².
Primary endpoint: HbA1c values after one year.
Main secondary endpoint: Remission rate of diabetes mellitus type 2 (HbA1c <6.5% without any antidiabetic medication) after 1 year.
Weight loss, visceral fat mass, therapy costs and need of medication for other co-morbidities are also investigated.

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Organizational Data

  •   DRKS00007810
  •   2015/05/21
  •   [---]*
  •   yes
  •   Approved
  •   153-15-20042015, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   U1111-1167-1614 
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Health Condition or Problem studied

  •   E11 -  Non-insulin-dependent diabetes mellitus
  •   E66.0 -  Obesity due to excess calories
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Interventions/Observational Groups

  •   Roux-en-Y gastric bypass with formation of a gastric pouch (10-20 cm³) and bypass of the proximal small bowel with the following limb lengths:
    BMI≥50 kg/m²: alimentary limb 170 cm, biliopancreatic limb 80 cm.
    BMI<50 kg/m²: alimentary limb 150 cm, biliopancreatic limb 50 cm.
  •   Roux-en-Y gastric bypass with formation of a gastric pouch (10-20 cm³) and bypass of the proximal small bowel with changed limb lengths:
    BMI≥50 kg/m²: alimentary limb 80 cm, biliopancreatic limb 170 cm.
    BMI<50 kg/m²: alimentary limb 50 cm, biliopancreatic limb 150 cm.
  •   Observational control arm with standard medical diabetes treatment
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Characteristics

  •   Interventional
  •   [---]*
  •   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

HbA1c value after one year

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Secondary Outcome

Remission rate of diabetes mellitus type 2 (HbA1c<6.5% without any antidiabetic medication) after one year

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/06/13
  •   160
  •   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 ≥27 to ≤60 kg/m²;
- for BMI≥35: any Diabetes mellitus type 2;
- for BMI < 35 kg/m²: Diabetes mellitus type 2 with unsatisfactory medical non-insulin treatment (multiple medications, HbA1c >6.5%, hypo- or hyperglycaemias), or planned insulin treatment or ongoing insulin Treatment;
- written informed consent

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Exclusion Criteria

- any chronic inflammatory or malignant disease; - type 1 diabetes; - peptic ulcer; - contraindication for general anaesthesia; - drug or alcohol abuse; - untreated thyroid dysfunction; - pregnancy or breast feeding woman; - expected non-compliance; - participation in other interventional trials requiring insurance

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Addresses

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    • Universitätsklinikum Leipzig AöRKlinik u. Poliklinik für Visceral-, Transplantations-, Thorax- u. Gefäßchirurgie Bereich Bariatrische Chirurgie
    • Mr.  Prof. Dr. med.  Arne  Dietrich 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig AöRKlinik u. Poliklinik für Visceral-, Transplantations-, Thorax- u. Gefäßchirurgie Bereich Bariatrische Chirurgie
    • Mr.  Prof. Dr. med.  Arne  Dietrich 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig AöRKlinik u. Poliklinik für Visceral-, Transplantations-, Thorax- u. Gefäßchirurgie Bereich Bariatrische Chirurgie
    • Mr.  Prof. 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 ongoing
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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.