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)

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) - BARO-DIET

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000686

Enrollment

Registered

2011-01-17

Start date

2011-04-26

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E66.82

Interventions

Group 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 Group 2: Low energy diet 2 (LED2,

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Germany

Contacts

Public ContactTatjana Schütz

Integriertes Forschungs- und Behandlungszentrum AdipositasErkrankungen

tatjana.schuetz@medizin.uni-leipzig.de0341/ 97 15 957

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026