Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00017718

Trial Description

start of 1:1-Block title

Title

Examination of back pain and serum-leptin in patients with weight loss after bariatric surgery

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

Trial Acronym

[---]*

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

This study will be an observational study in severely obese patients undergoing obesity surgery. In addition, the incidence and postoperative change of back pain (and associated markers) in questionnaires should be investigated in these patients. Furthermore, the change of the serum marker leptin should be analyzed by a simple blood analysis. The purpose of the study is to generate data on the basis of a large, clearly defined patient group (n = 500) which should provide information on whether weight loss is a preventive method in spinal medicine and whether serumleptin in this patient population has prognostic relevance.

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

Brief Summary in Scientific Language

Over the past three decades the prevalence of obesity has doubled worldwide, leaving 12.8% of Europeans with a body mass index (BMI) of above 30. In the recent past a possible link between obesity, back pain and disc degeneration has been discussed, for example due to abnormal biomechanical stress on the body, decreased muscle mass or increased systemic inflammation. A possible link would be particularly important as both obesity and back pain cause a large part of our current health care costs and contribute significantly to inability to work.
However, previous data on groups of patients with a wide variation of the BMI show no clear association between obesity and back pain. On the other hand, it has recently been shown that severely overweight patients have largely reduced their back pain by losing weight as a result of obesity surgery. However, this study included only a small group of 50 patients and thus can not be considered sufficiently representative.
If obese individuals were indeed more likely to have back pain but could reduce it by losing weight, this would give valuable preventive approaches to spinal medicine. It would be ideal to have a simple marker (detectable, for example, by means of blood tests) with which one could individually predict the expected improvement (benefit) of a weight loss for each obese patient ("personalized medicine and diagnostics"). The serum marker leptin, a inflammatory marker produced by fat cells, for which pain association in various diseases (e.g., osteoarthrosis) could already be shown could be such a marker.

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

Organizational Data

  •   DRKS00017718
  •   2019/08/28
  •   [---]*
  •   yes
  •   Approved
  •   PV5795, Ethik-Kommission der Ärztekammer Hamburg
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

  •   E66.82 -  [generalization E66.8: Other obesity]
  •   M54.99 -  [generalization M54.9: Dorsalgia, unspecified]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   500 consecutive patients will be enrolled in this study.
    Preoperatively as well as at the time points 6, 12 and 24 months postoperatively a survey on the intensity of back pain, quality of life and determination of serum-leptin will be carried out.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Presence and change in intensity of back pain in morbidly obese patients both pre- and postoperative, correlation between Change in back pain and weight reduction

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

Secondary Outcome

Presence and change of leg pain, quality of life, ability to work after weight-loss surgery.

Levels of serum leptin pre- and postoperative.

Correlation between all parameters.

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

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

Recruitment

  •   Actual
  •   2019/05/16
  •   500
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Bariatric surgery planned between April 2018 to March 2020.
Signed informed consent.

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

Exclusion Criteria

Previous back-surgery or back-trauma, tumor, rheumatic diseases. No informed consent.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Schön Klinik Hamburg Eilbek
    • 22081  Hamburg
    • 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
    • Adipositas Klinik der Schön Klinik Hamburg Eilbek
    • Mr.  Dr.  Johannes  Sander 
    • Dehnhaide 120
    • 22081  Hamburg
    • 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
    • Adipositas Klinik der Schön Klinik Hamburg Eilbek
    • Mr.  Dr.  Johannes  Sander 
    • Dehnhaide 120
    • 22081  Hamburg
    • 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
    • Deutsche Wirbelsäulenstiftung
    • Mr.  Prof. Dr. biol. hum.  Hans-Joachim  Wilke 
    • Helmholtzstraße 14
    • 89081  Ulm
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
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.