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Mechanisms of hepatic fat reduction through nutritional strategies in patients with indication for bariatric surgery

Mechanisms of hepatic fat reduction through nutritional strategies in patients with indication for bariatric surgery - LEMBAS (Diet-induced Changes in Liver fat and Energy Metabolism prior to BAriatric Surgery)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00009509
Enrollment
60
Registered
2016-02-25
Start date
2016-01-29
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: Hypocaloric high-protein diet (1500kcal, 35% protein, 30% fat, 35% carbohydrates) for 3 weeks before surgery Group 2: Hypocaloric low-protein low-methionine diet (1500 kcal, 10% protein, 30%

Sponsors

Deutsches Institut für Ernährungsforschung Potsdam- Rehbrücke, Abteilung Klinische Ernährung
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 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: 1. Taking medications that lead to insulin resistance (cortisol, growth hormone, rheumatism) 2. Chemotherapy within 8 weeks before surgery 3. An advanced liver disease (cirrhosis) 4. Patients who have already received an organ transplant 5. Patients with severe infectious disease 6. Any factors that limit the ability of the patient to cooperate during study ( mental function or drug abuse)

Design outcomes

Primary

MeasureTime frame
Change of liver fat content after three weeks of dietary intervention using MRT scan (t0: before diet; t1: after three weeks of diet)

Secondary

MeasureTime frame
Anthropometrical measurements (weight, height, waist circumference); blood pressure and electrocardiogram; visceral fat mass using MRT scan; abdominal subcutaneous fat mass using MRT scan; total fat mass (BIA and BodPod measurements); fat-free mass (BIA and BodPod measurements); analysis of glucose metabolism using oral glucose tolerance test; routine biochemistry of liver and kidney parameters in blood and urine samples (gamma GT, ALAT, ASAT, LDL cholesterol, HDL cholesterol, triglycerides etc.); measurement of serum marker of liver fat (cytokeratin 18, fetuin A, FGF21), inflammation markers (IL18, IL6, TNFa, progranulin, chemerin), hormones of glucose metabolism (insulin, C-peptide, glucagon), adipokines (adiponectin, leptin) using ELISA; these measurements are performed before (t0) and after three weeks of dietary intervention (t1). Histological analysis of liver, visceral and subcutaneous adipose tissue; gene expression in the liver, visceral and subcutaneous adipose tissue using real-time PCR; protein expression in the liver, visceral and subcutaneous adipose tissue using western blot; mitochondrial activity in liver using OROBOROS; these measurements are performed after three weeks of dietary intervention (t1).

Countries

Germany

Contacts

Public ContactSilke Hornemann

Deutsches Institut für Ernährungsforschung Potsdam-Rehbrücke, Abteilung Klinische Ernährung

silke.hornemann@dife.de(0332)00882791

Outcome results

None listed

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