Trial document




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  DRKS00015891

Trial Description

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Title

Body composition, mitochondrial oxygen metabolism and metabolome of obese patients before and after bariatric surgery

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Trial Acronym

COMMITMENT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Severe overweight (obesity) disrupts many metabolic pathways and organ systems. In many cases, when life-style interventions are unsuccessful, a surgical operation (so-called bariatric surgery) can achieve therapeutic success. Usually, an intentional profound weight loss can be observed.
It remains unclear, which role the metabolism of the mitochondria, the power suppliers of the cell, play in this positive effect. The aim of this study is to analyze the influence of bariatric surgery on the amount of body fat as well as on mitochondrial function. Furthermore, we aim to characterize more closely the medical condition obesity through laboratory tests including metabolic and immunological analyses.
To this aim, the patients' medical history will be documented during pre-assessment and follow-ups. Blood tests will be performed in addition to the routine blood test. Furthermore, mitochondrial oxygen tension and consumption will be measured as well as the body’s fat, muscle and water percentage. During the operation, biopsies of skeletal muscle, stomach and fatty tissue will be performed.

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Brief Summary in Scientific Language

Obesity signifies a great burden for health systems worldwide. It is a known risk factor for the most common global causes of death and part of the metabolic syndrome which also includes arterial hypertension, impaired glucose tolerance and dysfunctional lipid metabolism. Aside from conservative therapy (diet, exercise), bariatric surgery can achieve weight loss in severe cases.
Positive effects of this type of operation have been reported. However, the link to a dysfunction of the mitochondria has not been established. A first study in mice showed a connection between mitochondrial function and the metabolome, especially lipidome. A study in rodents demonstrated that obesity inhibited mitochondrial function. There is initial evidence that bariatric surgery can improve mitochondrial function. The metabolome can be analyzed by mass spectrometry which will be performed in this study.
Recently, a novel technique (COMET) for the measurement of mitochondrial oxygen tension (mitoPO2), consumption (mitoVO2) and delivery (mitoDO2) has been developed.
Thus far, only few studies on the influence of bariatric or metabolic surgery on mitochondrial dysfunction exist. The two parameters mitoPO2 and mitoVO2 will act as surrogate parameters of mitochondrial function in this study.
Bariatric surgery has a profound effect on body weight. Especially in the first year, patients lose about 50–70% of surplus weight. To measure which body compartments (body fat, water, muscle tissue) are most affected, and to analyze the effect of body composition on COMET analysis, bio-impedance measurements will be performed.
In order to analyze the effect of bariatric surgery on body composition and mitochondrial function, the patients’ medical history will be documented during pre-assessment and follow-ups. Blood tests will be performed in addition to the routine blood test. Furthermore, mitochondrial oxygen tension and consumption will be measured as well as the body’s fat, muscle and water percentage. During the operation, biopsies of skeletal muscle, stomach and fatty tissue will be performed.

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Organizational Data

  •   DRKS00015891
  •   2019/01/31
  •   [---]*
  •   yes
  •   Approved
  •   2018-1192-BO, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   E66.92 -  [generalization E66.9: Obesity, unspecified]
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Interventions/Observational Groups

  •   Time points and analyses
    T0 (pre-operative): standardised medical history, bio-impedance analysis, blood samples, COMET measurement.
    T1 (operation): biopsies
    T2 (3 +/-1 months after surgery): standardised medical history, bio-impedance analysis, blood samples
    T3 (6 +/-1 months after surgery): standardised medical history, bio-impedance analysis, blood samples, COMET measurement
    T4 (9 +/-1 months after surgery): standardised medical history, bio-impedance analysis, blood samples
    T5 (12 +/-1 months after surgery): standardised medical history, bio-impedance analysis, blood samples, COMET measurement
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Characteristics

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

Change in relative fat mass 6 months after surgery compared with the pre-operative state.

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Secondary Outcome

1.) Change in mitochondrial oxygen metabolism (mitoPO2, mitoVO2 and mitoDO2) 6 and 12 months after surgery compared with before the operation.
2.) Explorative analyses of the relationship between bio-impedance analysis parameters and mitoPO2 and mitoVO2 values 6 and 12 months after surgery compared with before the operation.
3.) Changes in body composition, especially visceral fat and muscle mass before the operation compared with 3, 6, 9 and 12 months after.
4.) Influence of bariatric surgery on laboratory parameters, specifically metabolome, lipidome, immune function and epigenetics.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/02/26
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1.) Grad 3 obesity with BMI ≥40 kg/m2 and significant metabolic comorbidity, EOSS (Edmonton Obesity Staging System) stage ≥ 2 with truncal obesity
2.) written informed consent

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Exclusion Criteria

1.) Contra-indications to bio-impedance and COMET analysis
2.) Pregnancy or breastfeeding period
3.) Participation in another interventional study
4.) Prior participation in this study

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Addresses

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    • NWG Translational Septomics, Zentrum für Innovationskomepetenz (ZIK) Septomics, Universitätklinikum Jena
    • Ms.  Dr.  Sina  Coldewey, PhD 
    • Am Klinikum 01
    • 07747  Jena
    • Germany
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    • NWG Translational Septomics, Zentrum für Innovationskompetenz (ZKS) Septomics, Universitätsklinikum Jen
    • Mr.  Kornel  Skitek 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • NWG Translational Septomics, Zentrum für Innovationskompetenz (ZKS) Septomics, Universitätsklinikum Jen
    • Mr.  Kornel  Skitek 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  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.