Trial document




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  DRKS00011537

Trial Description

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Title

Changes in metabolome and epigenome after drastic weight loss and identification of novel forms of monogenetic obesity

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Our aim is to gain knowledge of changes in the human body which occur during great weight reduction. Therefore, we survey patients undergoing long-term weight loss therapy due to lifestyle changes. We will focus our analysis on metabolic and epigenetic changes. Epigenetic is a relatively new field of science. It analyses how parts of DNA get read. Alterations in epigenetic can occur rapidly due to environmental changes (e.g. nutrition, sport) and may lead to metabolic changes.
In recent years scientists could identify few subjects with rare monogenetic forms of obesity. This means that some (even if only approx.3 %) of obese people carry a mutation in their genetic material which is responsible for the extreme obesity. Such genes mostly influence the so called leptin-melanocortin pathway which is a main actor in regulation of hunger and satiety.
In the course of this study we try to identify patients which are carrier of those rare variants. We further want to investigate metabolic and epigenetic changes occurring during weight reduction and compare “good weight reducer” vs. “low weight reducer”.

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Brief Summary in Scientific Language

Extreme obese adolescents will be surveilled on an average of six months while living under controlled conditions. During this worldwide unique long-term care the patients will lose greatly weight. The success is comparable with weight reduction after bariatric surgery. The Ulm University Medical Center (Division of Pediatric Endocrinology and Diabetes) wants to cooperate with some of those patients and investigate epigenetic and metabolic changes after great weight loss. The aim of this study is to gain knowledge about metabolic changes which occurred during weight reduction. We want to understand the underlying physiology and apply our knowledge to improve obesity therapy. Further, when there is a suspicion of an underlying monogenetic cause for the obesity we want to sequence the patients genome.
With this work we want to investigate three main questions
H0.1: How do hormones/metabolic parameter change during weight reduction phase (comparison “good weight reducer” vs. “low weight reducer” *)
H0.2: How does epigenetic change during weight reduction phase (comparison “good weight reducer” vs. “low weight reducer” *)
H0.3: Is there a underlying monogenetic cause for the extreme obesity.
The collected data will be analyzed descriptively

* good weight reducer is defined as > 1,5 kg loss in body weight per week.
Low weight reducer is defined as < 0,5 kg loss in body weight per week.

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Organizational Data

  •   DRKS00011537
  •   2017/01/20
  •   [---]*
  •   yes
  •   Approved
  •   355/16, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   Extreme Obesity
  •   Genetic disposition
  •   E66 -  Obesity
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Interventions/Observational Groups

  •   Due to live style modification in context of a long-term obesity therapy adolescent will undergo great weight loss. We want to compare metabolic and epigenetic changes before and after weight loss. Further we want to compare “good weight reducer” vs. “low weight reducer”
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Characteristics

  •   Non-interventional
  •   Observational study
  •   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

Changes in the metabolome and epigenome during lifestyle interventions. Therefore, we evaluate blood samples taken on the first and last day of long-term weight loss therapy. Blood samples are taken routinely before and after therapy.

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Secondary Outcome

Comparison between “good weight reducer” vs. “low weight reducer” on the basis of weight development and metabolic/epigenetic parameters. Exclusion of underlying monogenetic causes of obesity by observation of weight development and metabolic parameter.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/01/08
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   10   Years
  •   30   Years
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Additional Inclusion Criteria

Extreme Obesity

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Exclusion Criteria

Subject do not want genetic analysis. Obesity is caused by underlying disease e.g. Brain tumor, Prader-Willi syndrome…

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Addresses

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    • Universitätsklinikum Ulm für Kinder- und JugendmedizinSektion Pädiatrische Endokrinologie u. Diabetologie, Interdisziplinäre Adipositasambulanz
    • Mr.  Prof. Dr.  Martin  Wabitsch 
    • Eythstraße 24
    • 89075  Ulm
    • Germany
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    • Sektion Pädiatrische Endokrinologie und DiabetologieInterdisziplinäre AdipositasambulanzUniversitätsklinik für Kinder- und Jugendmedizin UlmUniversitätsklinikum Ulm
    • Ms.  M.Sc.  Adriana  Nunziata 
    • Eythstraße 24
    • 89075  Ulm
    • Germany
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    • Sektion Pädiatrische Endokrinologie und DiabetologieInterdisziplinäre AdipositasambulanzUniversitätsklinik für Kinder- und Jugendmedizin UlmUniversitätsklinikum Ulm
    • Ms.  M.Sc.  Adriana  Nunziata 
    • Eythstraße24
    • 89075 Ulm  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Ulm für Kinder- und Jugendmedizin Sektion Pädiatrische Endokrinologie u. Diabetologie, Interdisziplinäre Adipositasambulanz
    • Mr.  Prof.Dr.Med  Martin  Wabitsch 
    • Eythstraße 24
    • 89075  Ulm
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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