Trial document




drksid header

  DRKS00000686

Trial Description

start of 1:1-Block title

Title

Influence of different preoperative low energy diets on changes in liver volume, liver fat content, visceral fat and body composition as well as liver and adipose tissue mRNA expression in bariatric patients (BARO-DIET)

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

Trial Acronym

BARO-DIET

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

In patients with severe obesity the liver is very large and fat has accumulated within the abdominal cavity. Before weight loss surgery liver size and intra-abdominal fat should be reduced. This can be achieved by special low energy diets. It is, however, unknown whether diets of different nutrient composition have different effects on liver volume, liver fat content and body fat. Therefore, we compare two different low energy diets of different nutrient composition over a period of 14 days in patient waiting for weight loss surgery.

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

Brief Summary in Scientific Language

Preoperative low energy diet (LED) before bariatric surgery was shown to be effective to reduce the liver size and visceral adipose tissue. However, it is unknown, whether different preoperative diet interventions have different effects on the liver volume, liver fat content and changes in visceral as well as in subcutaneous adipose tissue reduction in patients undergoing bariatric surgery. We will, therefore, compare two low energy diets of different macronutrient composition over a period of 14 days preoperatively in a prospective randomized study of 72 individuals with the indication for a bariatric procedure.

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

Organizational Data

  •   DRKS00000686
  •   2011/01/17
  •   [---]*
  •   yes
  •   Approved
  •   363-10-13122010, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1119-0341 
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]
  •   [---]* -  [---]*
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Low energy diet 1 (LED1, BCM Diät™, PreCon GmbH, Darmstadt) containing 75 g protein, 28 g fat, and 80 g carbohydrate over a period of 14 days preoperatively
  •   Low energy diet 2 (LED2, Optifast™, Nestle HealthCare Nutrition GmbH, München) containing 58 g protein, 19 g fat, and 111 g carbohydrate over a period of 14 days preoperatively
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Changes in liver volume as determined by MRI scans after two weeks of a low energy diet
(t0: before start of the diet; t1: after two weeks of diet)

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

Secondary Outcome

Liver fat content as determined by 1H-NMR spectroscopy;
Visceral adipose tissue area as determined by MRI scans at the level of L4-L5;
Abdominal subcutaneous fat area as determined by MRI scans at the level of L4-L5;
Total body fat mass (BIA measurement);
Total body cell mass (BIA measurement);
General well being (SF 36);
Gastrointestinal Quality of Life Index (GIQLI);
Serum concentrations of Bilirubin, Gamma GT, Alkaline Phospahtase, ALAT, ASAT, LDL-cholesterol, HDL-cholesterol, Triglycerides;
Dietary intervention related differences in unrecognized gene expressions in the liver (microarray analysis in a subgroup of n=15 per diet group);
Dietary intervention related differences in unrecognized gene expressions in omental and subcutaneous adipose tissue (microarray analysis in a subgroup of n=15 per diet group);
Dietary intervention related differences in liver and adipose tissue mRNA expression of fatty acid synthase, SREBP1c, ChREBP, RBP4, CPT1 und 2, IL-6, IL-1beta, CD36, HSL, ATGL, LPL, FTO and other obesity candidate genes
All measurements are performed before start of the diet (t0) and after two weeks of diet (t1)

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
  •   2011/04/26
  •   72
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Obese patients with BMI > 40 kg/m² or BMI > 35 kg/m² and obesity related co-morbidities (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnoe syndrome

Failed 6 months multimodal standardized conservative obesity therapy

Indication for bariatric procedure

Written informed consent

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

Exclusion Criteria

Any chronic inflammatory or malignant disease
drug abuse;
alcohol (intake (>20 g/day);
psychiatric disorders;
untreated thyroid dysfunction;
pregnancy or lactation;
systemic corticoid steroid therapy (> 2 mg/d Prednisolone);
lactose intolerance;
participation in any other interventional trial;
contraindication to MRI or MRI not feasible

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Department für Operative Medizin Klinik f. Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie Sektion Bariatrische Chirurgie Universitätsklinikum Leipzig AöR
    • Mr.  PD Dr. med.  Arne  Dietrich 
    • Liebigstr. 20
    • 04103  Leipzig
    • 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
    • Department für Operative Medizin Klinik f. Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie Sektion Bariatrische Chirurgie Universitätsklinikum Leipzig AöR
    • Mr.  OA Dr. med.  Arne  Dietrich 
    • Liebigstr. 20
    • 04103  Leipzig
    • 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
    • Integriertes Forschungs- und Behandlungszentrum AdipositasErkrankungen
    • Ms.  Dr. rer. nat.  Tatjana   Schütz 
    • Stephanstr. 9c
    • 04103  Leipzig
    • 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
    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • 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 complete, follow-up complete
  •   2013/04/05
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.