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)

Transcription

1 Trial Description 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) Trial Acronym BARO-DIET URL of the trial [---]* 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. 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. Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: [---]* Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: , Ethikkommission an der Medizinischen Fakultät der Universität Leipzig Page 1 of 6

2 Secondary IDs Universal Trial Number (UTN): U Health condition or Problem studied ICD10: E [generalization E66.8: Other obesity] ICD10: [---]* - [---]* Interventions/Observational Groups Arm 1: 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 Arm 2: 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 Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: [---]* Who is blinded: [---]* Control: Active control (effective treament of control group) Purpose: Treatment Assignment: Parallel Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): [---]* 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) 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- Page 2 of 6

3 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, LDLcholesterol, 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) Countries of recruitment DE Locations of Recruitment Medical Center Universitätsklinikum Leipzig, Leipzig Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2011/04/26 Target Sample Size: 72 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 18 Years Maximum Age: 65 Years 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 Page 3 of 6

4 Failed 6 months multimodal standardized conservative obesity therapy Indication for bariatric procedure Written informed consent 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 Addresses 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 Telephone: 0341/ Fax: 0341/ arne.dietrich at uniklinik-leipzig.de URL: Contact for Scientific Queries 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 Telephone: 0341/ Fax: 0341/ arne.dietrich at uniklinik-leipzig.de Page 4 of 6

5 Contact for Scientific Queries 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 Telephone: 0341/ Fax: 0341/ arne.dietrich at uniklinik-leipzig.de URL: Contact for Public Queries Integriertes Forschungs- und Behandlungszentrum AdipositasErkrankungen Ms. Dr. rer. nat. Tatjana Schütz Stephanstr. 9c Telephone: 0341/ Fax: 0341/ tatjana.schuetz at medizin.uni-leipzig.de URL: Sources of Monetary or Material Support Public funding institutions financed by tax money/government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.) Bundesministerium für Bildung und Forschung Dienstsitz Berlin Friedrichstraße 130 B Berlin Telephone: [---]* Fax: [---]* [---]* URL: Status Recruitment Status: Recruiting complete, follow-up complete Study Closing (LPLV): 2013/04/05 Page 5 of 6

6 Trial Publications, Results and other documents Paper [---]* * This entry means the parameter is not applicable or has not been set. Page 6 of 6