Trial document




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  DRKS00015814

Trial Description

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Title

Unbiased DECONvolution of obesity

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Trial Acronym

DECON

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Current BMI-based classification of obesity is very pragmatic and feasible, but does not allow diagnostic or prognostic differentiation between patient subgroups.
Even under highly standardized therapeutic conditions patients with identical BMI-values and similar co-morbidity differ greatly regarding postoperative weight loss and remission of associated disease. Treatment success is often defined as >50% Excess Weight Loss. This definition implies obese patients with similar BMI-values and comparable co-morbidity will fair comparably well. This does not reflect clinical reality that shows considerable deviations regarding weight loss.
There are various subgroups of obesity patients that differ in etiology, predisposition and treatment prognosis. This study serves as a pilot study to unterstand more clearly the diversity of patient subsets that exist on the basis of unbiased, high-dimensional data and to create the basis of a new classification system. In the pilot phase, we collect preliminary data, establish analytical pipelines and optimize bioinformatic approach.

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Brief Summary in Scientific Language

Prevalence of overweight and obesity has been increasing worldwide in the past years. Obesity is a chronic disease with a high rate of recurrence and countless associated diseases, first and foremost diabetes. Disease etiology is very complex. A positive energy balance, which is aggravated by increasing sedentary behavior and easy access to high-caloric foods plays a central role. Genetics, family predisposition and environmental factors contribute to an individual's risk profile. Furthermore, in the past years data has been obtained underlining the importance of intergenerational metabolic programming on an epigenetic level.
Obesity is still very poorly understood on many levels. Current classification systems reflect this and employ pragmatic criteria, almost exclusively BMI-oriented.
We plan in a multi-center trial and in collaboration with the Max Planck Institut für Immunbiologie und Epigenetik to examine a large patient population to create the foundation of a new and more precise classification system. Patient clustering will be achieved on the basis of unbiased high-dimensional sequencing data. These data will be correlated with clinical parameters. Our goal is to individualize diagnosis and treatment prognosis of obesity patients. During the pilot phase we plan to establish logistics and analytic pipelines as well as optimize bioinformatic approach.

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Organizational Data

  •   DRKS00015814
  •   2018/11/09
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  •   yes
  •   Approved
  •   194/18, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1212-4671 
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Health Condition or Problem studied

  •   E66 -  Obesity
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Interventions/Observational Groups

  •   Liver and adipose biopsies during bariatric/metabolic surgery
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

This study has no comparative outcome. The focus lies in its bioinformatic approach which relies on dimensional reduction and clustering of RNAseq-data and quantifiable clinical parameters to define patient clusters. In this way the entire spectrum currently globally termed as obesity will be more precisely defined.

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Secondary Outcome

see primary outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/11/26
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   49   Years
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Additional Inclusion Criteria

1) Obesity WHO III (BMI>40 kg/m2)
2) Obesity WHO II (BMI 35-40 kg/m2) + obesity related diseases (diabetes, hypertension, hyperlipidemia, osteoarthrosis, obstructive sleep apnea, obesity hypoventilation syndrome, nonalcoholic fatty liver disease (NAFLD) and/or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease, asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, impaired quality of life, disqualification for other surgeries as a result of obesity (i.e., surgeries for osteoarthritic disease, ventral hernias, or stress incontinence)
Female, caucasian, >=18 years <50 years

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Exclusion Criteria

Patients with high perioperative risk, previous bariatric surgery, carcinoma within the last 5 years,
severe psychiatric disease, drug or alcohol abuse,

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Addresses

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    • Universitätsklinikum FreiburgKlinik für Allgemein- und Viszeralchirurgie
    • Mr.  Dr.  Gabriel  Seifert 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Max-Planck-Institut für Immunbiologie und Epigenetik
    • Mr.  Dr.  Andrew  Pospisilik 
    • Stübeweg 51
    • 79108  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Allgemein- und Viszeralchirurgie
    • Mr.  Dr.  Gabriel  Seifert 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abteilung Allgemien- und Viszeralchirurgie
    • Ms.  Olivia  Sick 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Max-Planck-Institut für Immunbiologie und Epigenetik
    • Mr.  Dr.  Andrew  Pospisilik 
    • Stübeweg 51
    • 79108  Freiburg
    • Germany
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Status

  •   Recruiting planned
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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.