Trial document




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  DRKS00013992

Trial Description

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Title

Prospective study for the clinical evaluation of fat-soluble vitamins (ADEK) after obesity surgery
(Roux-Y stomach bypass, tube stomach)

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Trial Acronym

adiADEK

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URL of the Trial

[---]*

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Brief Summary in Lay Language

What is the background of the study?
Many references describe a vitamin deficiency of the fat-soluble vitamins ADEK already before an obesity operation and that this deficiency can develop further after an obesity operation. This is why we initiated the adiADEK study, in the hope that this study will enable us to make a statement on the deficiencies of fat-soluble vitamins.

What will be done?
In order to also improve the diagnostic possibilities, we want to examine during the obesity surgery automatically accumulating samples of the fatty tissue as well as extra taken liver tissue for the content of fat-soluble vitamins. In addition, the 4 fat-soluble vitamins are routinely checked during follow-up appointments using blood samples.

Who are the potential study participants?
Anyone who meets the criteria for obesity surgery and has decided to undergo an operation (stomach bypass or gizzard) has the opportunity to participate in this study.
None of the exclusion criteria may exist:
Pregnancy
lack of own ability to give consent.

What is the aim of the study?
The main objective of this study is to investigate the development of a vitamin deficiency of fat-soluble vitamins A, D, E and K after surgical treatment of obese patients with gastric bypass or gastrointestinal tract.
A secondary objective is to show a possible reference of the vitamin content between blood level and tissue samples by examining the vitamin content of the tissue samples taken on the day of the operation. This is intended to provide a more reliable statement about vitamin deficiencies, which means an improvement of the current diagnostic method.

What hypotheses are being examined?
Does the content of fat-soluble vitamins decrease despite oral vitamin supplementation after obesity surgery?

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Brief Summary in Scientific Language

The study is used to generate hypotheses. It is a prospective observational study after obesity surgery (Roux-en-Y gastric bypass, tube stomach).
The vitamin supply of fat-soluble vitamins (AEDK) under oral supplementation is to be investigated and documented over 1 year postoperatively. In addition, a possible correlation between the vitamin A content in serum and tissue will be investigated and other prognostic markers for vitamin A deficiency will be identified.
After oral and written explanations of the patients, the parameters collected in the blood within the framework of the standard therapy are to be evaluated. In addition, tissue samples are to be obtained from the residual samples of the operation and the parameters described below are to be investigated. In addition, liver tissue will also be removed.
The present study is a prospective cohort study.

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Organizational Data

  •   DRKS00013992
  •   2018/02/15
  •   [---]*
  •   yes
  •   Approved
  •   F-2017-091, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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

  •   E66 -  Obesity
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Interventions/Observational Groups

  •   There is a group of patients.
    The vitamin content of all participants is measured during the operation and then at regular intervals. The measurement is carried out once after the operation on the basis of tissue samples (fat and liver tissue) and also regularly on the basis of blood samples.

    Participants take vitamin chewing tablets 2 times daily (PZN- 12442849)
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Measurements:
For each order, the following patient data is collected in a pseudonymised form.
1. BIA (bioimpedance analysis) measurement with Seca scale type mBCA 515 with all evaluation parameters
2. blood sampling
a. standard laboratory
b. Vitamins A, D, E, K, RBP
c. Adipokine biomarkers (including leptin, RBP4, etc.)

Additionally during the operation:
1. removal of subcutaneous fat
2. removal of visceral fat
3. removal of liver tissue
4. sample from removed tissue (gastrointestinal tract)

The following parameters are determined for tissue samples:
1. vitamin A
2. RBP
3. adipokine biomarkers (including leptin, RBP4, etc.)


Measuring times:
T-1 Discussion and examination 14 days to 3 weeks before scheduled surgery
T 0 Operation date: 1 day before standard laboratory
T 1 Discussion and examination 4 weeks after surgery
T 2 Discussion and examination 3 months after surgery
T 3 Discussion and examination 6 months after surgery
T 4 Discussion and examination 9 months after surgery
T 5 Discussion and examination 12 months after surgery

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Secondary Outcome

not available

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/02/19
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Applicable study participants are all patients who have received reimbursement from the health insurance company after MDK examination and thus meet the strict inclusion criteria according to the current S3 guideline for obesity surgery.

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Exclusion Criteria

- Pregnancy
- lack of own ability to give consent
- Participation in a clinical trial within the last 4 weeks prior to and during the trial

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Addresses

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    • Ernährungsmedizin Institut Biologische Chemie und Ernährungswissenschaft der Universität Hohenheim
    • Mr.  Professor Dr. med.  Hans Konrad  Biesalski 
    • Wollgrasweg 43
    • 70593  Stuttgart
    • Germany
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    • Ernährungsmedizin Institut Biologische Chemie und Ernährungswissenschaft der Universität Hohenheim
    • Mr.  Professor Dr. med.  Hans Konrad  Biesalski 
    • Wollgrasweg 43
    • 70593  Stuttgart
    • Germany
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    • Chefarzt für Allgemein- und ViszeralchirurgieAdipositaszentrum Stuttgart Sana Klinik Bethesda Stuttgart
    • Mr.  Dr. med.  Matthias C.  Raggi 
    • Hohenheimer Str. 21
    • 70184  Stuttgart
    • Germany
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Sources of Monetary or Material Support

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    • Chefarzt für Allgemein- und ViszeralchirurgieAdipositaszentrum Stuttgart Sana Klinik Bethesda Stuttgart
    • Mr.  Dr. med.  Matthias C.  Raggi 
    • Hohenheimer Str. 21
    • 70184  Stuttgart
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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