Trial document





This trial has been registered retrospectively.
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  DRKS00003087

Trial Description

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Title

Effect of an interdisciplinary multimodal long-term weight reduction program on left ventricular diastolic function in morbid obesity

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Left ventricular diastolic heart failure has been repeatedly shown to be associated with obesity and the metabolic syndrome. However, it is not known whether an intensive long-term weight reduction program improves diastolic function. Thus, we investigate whether a long-term weight reduction program is able to improve left ventricular diastolic function in subjects with obesity.

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Brief Summary in Scientific Language

Left ventricular diastolic heart failure has been repeatedly shown to be associated with obesity. However, it is not known whether an intensive long-term weight reduction program improves diastolic function. In this prospective longitudinal study, subjects with severe obesity and normal ejection fraction undergo detailed echocardiography, including blood flow and tissue Doppler assessment, as well as NTproBNP and GDF-15 measurements before and after a standardized 52 weeks weight reduction program. We hypothesize that a successfull participation in this weight reduction program improves left ventricular diastolic function. Moreover, we shall to evaluate predictors of diastolic dysfunction in severly obese men and women.

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Organizational Data

  •   DRKS00003087
  •   2011/06/15
  •   [---]*
  •   yes
  •   Approved
  •   05/001, Ethikkommission an der Universität Regensburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I50.12 -  [generalization I50.1: Left ventricular failure]
  •   E66.9 -  Obesity, unspecified
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Interventions/Observational Groups

  •   Successful participation in the Optifast-52 weight reduction program (Nestle Healthcare). The Optifast -52 program is a standardized multimodal program, encompassing dietetic treatment, physical activity and behavior therapy. The combination of these elements is leading to an effective weight control. In arm 1 treatment is successful, defined by weight reduction >10% at 3 and 12 months as well as re-gain of weight of <10% related to the minimally achieved body mass achieved by the hypocaloric diet phase.
  •   Unsuccessful participation in the weight reduction program, i.e. achieved weight reduction <10% after 3 or 12 months, or weight gain >=10% after hypocaloric diet phase.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Improvement of diastolic function 1 year after weight reduction

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Secondary Outcome

1. predictors of left ventricular diastolic dysfunction in obesity and the metabolic syndrome
2. predictive capability of heart failure biomarkers (NTproBNP, GDF-15) in severe obesity

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/07/20
  •   520
  •   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>30 kg/m2; constant body weight during the last 3 months

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Exclusion Criteria

pregnancy, consuming illnesses, addiction

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Addresses

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    • Klinik und Poliklinik für Innere Medizin II, Universitätsklinikum Regensburg
    • Ms.  Priv.-Doz. Dr. med.  Andrea  Baessler 
    • Franz-Josef-Strauss Allee 11
    • 93053  Regensburg
    • Germany
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    • Klinik und Poliklinik für Innere Medizin II, Universitätsklinikum Regensburg
    • Ms.  Priv.-Doz. Dr. med.  Andrea  Baessler 
    • Franz-Josef-Strauss Allee 11
    • 93053  Regensburg
    • Germany
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    • Klinik und Poliklinik für Innere Medizin II, Universitätsklinikum Regensburg
    • Ms.  Priv.-Doz. Dr. med.  Andrea  Baessler 
    • Franz-Josef-Strauss Allee 11
    • 93053  Regensburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Regensburg
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • 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.