Trial document




drksid header

  DRKS00004550

Trial Description

start of 1:1-Block title

Title

DiaSurg 2 trial - surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35 kg/m²

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Diasurg 2

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.klinikum.uni-heidelberg.de/Diabeteschirurgie.120580.0.html

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Approximately six million people in Germany are currently suffering from T2DM (Type 2 Diabetes Mellitus), among whom two million are insulin-dependent. A high proportion of these patients already suffer from T2DM-related diseases, such as micro- and/or macrovascular diseases resulting in neuro-, nephro-, retinopathy, myocardial infarction and stroke.The treatment of these comorbidities renders T2DM one of the most expensive diseases in terms of public health expenditure in Germany. Current guidelines recommend medical therapy for the treatment of T2DM as the gold standard.
Obesity starting from a body mass index (BMI) of 35 kg/m2 or more is considered a risk factor for the development of T2DM. For obese patients, bariatric surgery is recommended when conservative attempts do not result in substantial weight loss. Existing evidence reports that bariatric surgery not only leads to substantial weight loss, but also to T2DM remission in 42-78% of the patients who have undergone laparoscopic Roux-en-Y gastric bypass. In addition, T2DM-related diseases, such as cardiovascular diseases, nephropathy, retinopathy, neuropathy, hyperlipidemia and hypertension, are supposed to be avoided or at least delayed in their progress after metabolic surgery. The beneficial effects of bariatric surgery on T2DM appeared shortly after surgery,and before major weight loss, leading to the hypothesis that weight loss alone is not solely responsible for T2DM remission. In the Swedish Obese Subjects (SOS)-Study 35% of T2DM patients and 19% of patients suffering from preoperative hypertension were still in remission ten years after surgery.In an experimental study, Rubino et al. were able to prove that these effects are not dependent on weight loss alone. These findings led surgeons to perform bariatric procedures on non-severely obese patients (BMI < 35 kg/m2) suffering from T2DM. A recent randomized controlled, single-centre trial in patients with a BMI of 25–35 kg/m² showed T2DM remission in 93% of patients following Roux-en-Y gastric bypass and 47% of patients following laparoscopic gastric sleeve resection. The effect of T2DM remission could therefore also be shown in non-severly obese patients. In the present study 400 patients will be included and randomly assigned to either surgery or medical treatment and will be followed for 8 years.
Thus this randomized controlled multicentre trial assesses whether bariatric surgery can be used as an alternative in the primary care of T2DM, potentially leading to less strokes or cardiovascular death and thus preventing long-term morbidity and mortality well-known in T2DM patients.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This study aims at providing evidence as to whether Roux-en-Y gastric bypass surgery is an efficient method for Type 2 diabetes mellitus glycemic control in non-severely obese patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004550
  •   2012/12/20
  •   [---]*
  •   yes
  •   Approved
  •   S-285/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E11 -  Non-insulin-dependent diabetes mellitus
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Laparoscopic Roux-en-Y gastric bypass and standard medical care (S3 guidelines)
  •   Optimal medical care according to the national treatment guidelines for type 2 diabetes mellitus
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary endpoint is the time from randomization to one of the composite events, including death from cardiovascular causes, non-fatal myocardial infarction, coronary-artery bypass grafting, percutaneous coronary intervention, non-fatal stroke, amputation, and surgery for peripheral atherosclerotic artery disease during the follow-up period of eight years .

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary endpoints include the time to death from any cause and the time to each component of the primary endpoint. In addition, laboratory parameters for T2DM (HbA1c, C-peptide and glucagon stimulated C-peptide, fasting glucose, fasting insulin, oral glucose tolerance test), regular laboratory parameters (i.e. lipid profiles, serum creatinine, creatinin clearance) as well as vitamins and micronutrients (vitamin B6, B12, folate acid and iron status) are assessed. Additional parameters include the amount of medication (insulin dosage, metformin, antihypertensive therapy, etc.), the assessment of nephropathy (urine albumin excretion 24-hours urine sample), retinopathy (according to the EURODIAB six-level grading scale), peripheral neuropathy (assessed by biothesiometry of the big toe in both feet and questionnaire) and quality of life. Data assessment will be after randomization and then 3,6,12 months afterwards and then annually.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   2013/03/25
  •   Actual
  •   400
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Diagnosis of T2DM with insulin therapy for at least 3 months; Proof of at least one microvascular manifestation of diabetes (e.g., nephropathy, retinopathy, neuropathy);
Residual pancreatic function, which is the premise for autogenic glycaemic control assessed by stimulated fasting C-peptide laboratory tests with a minimum of 1.5 ng/ml; HbA1c at least 7%; ASA at least 3; BMI 26–35 kg/m²; Age 30–65 years;; beta cell autoantibody test for patients who recieved insulin therapy in the past year for diabetes mellitus type II; written informed consent; OK from board-certified endocrinologist

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Type I diabetes mellitus or latent autoimmune Diabetes in adults (LADA); T2DM on diet and/or oral medication; Heart failure (NYHA III–IV); instable angina pectoris; liver cirrhosis; glucocorticoid or other immunosuppressive therapy; puituitary disease/ M. Addison; renal failure (GFR < 45 ml/min); Pregnancy; malignant disease in the past 5 years (except basalioma); history of major abdominal operation; expected lack of compliance; participation in another interventional study with interference of intervention and outcome; inability to give consent

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universität Heidelberg
    • Mr.  Prof. Dr. med.  Markus W.  Büchler 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Allgemein-, Viszeral- und Transplantationschirugie, Universität Heidelberg
    • Mr.  Prof. Dr. med.  Beat P.  Müller 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universität Heidelberg
    • Mr.  Prof. Dr. med.  Beat P.  Müller 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Manfred Lautenschläger Stiftung
    • Im Breitspiel 9
    • 69126  Heidelberg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Covidien AG
    • Victor Von Bruns Strasse 19
    • 8212   Neuhausen am Rheinfall
    • Switzerland
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   0041 44 308 4848
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.