DRKS00021124CompletedNot Applicable
Multi-center, controlled cross-sectional analysis of the phenotype of malnutrition in patients with liver cirrhosis, chronic pancreatitis and short bowel Syndrome(as part of the Joint project Enteral nutrition in Malnutrition due to diseases of the gastrointestinal tract: from basic understanding to an innovative treatment concept (EnErGie)) - EnErGie cross-sectional study
Klinik für Innere Medizin, Abteilung für Gastroenterologie und Endokrinologie0 sites345 target enrollmentStarted: March 31, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 345
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •LIVER CIRRHOSIS:
- •- liver cirrhosis based on clinical and imaging criteria (sonography or CT or NMR) without evidence of hepatocellular carcinoma
- •- Child-Pugh Stadium A-C
- •CHRONIC PANCREATITIS:
- •- chronic pancreatitis based on imaging criteria (endoscopic ultrasound, CT, MRI / MRCP)
- •- large and small duct disease
- •- with or without exocrine insufficiency, with or without endocrine insufficiency
- •- patients after left pancreatic resection or pancreaticojejunostomy or duodenal pancreatic head resection can be included
- •SHORT BOWEL SYNDROME:
- •- short bowel Syndrome based on clinical anamnestic criteria and state after bowel resection followed by primary or secondary oral autonomy (intestinal failure)
- •CONTROL PATIENTS:
- •- patients without known underlying gastroenterological disease with an indication for esophago-gastro-duodenoscopy for symptom clarification
- •- gastroscopy without clinically relevant result (mild gastritis aspect, small axial hernia, typical glandular cysts, typical brunneromas can be included)
- •- ECOG performance status 0 or 1
- •HEALTHY CONTROLS:
- •- BMI 18.5 - 34.9 kg / m2
- •- ECOG performance status = 0
- •- participant considers to be healthy
- •- no malnutrition risk (NRS2002 <3)
- •- no sarcopenia according to EWGSOP/EWGSOP2
- •- weight stability in the past 6 months (< 5% weight fluctuation)
Exclusion Criteria
- •GENERAL EXCLUSION CRITERIA:
- •- parenteral nutrition in the previous 6 months
- •- continuing nutritional intervention (over more than the past 7 days, e.g. intake of oral nutritional supplements)
- •- pacemaker or implanted defibrillator
- •- pregnancy or lactation
- •- lack of ability to answer the questionnaires
- •- celiac disease
- •- coexistant chronic gastrointestinal disorders
- •SUBSEQUENT EXCLUSION OF CONTROL PATIENTS
- •- in the case of relevant, conspicuous esophago-gastro-duodenoscopy findings
- •SPECIFIC EXCLUSION CRITERIA
- •LIVER CIRRHOSIS:
- •- existing TIPS
- •- known HCC
- •- state after liver transplantation
- •CHRONIC PANCREATITIS:
- •- state after surgery with alteration of food flow (partial or total pancreaticoduodenectomy)
- •- known pancreatic carcinoma or state after therapy of pancreatic carcinoma (surgery or chemotherapy or radiation)
- •SHORT BOWEL SYNDROME:
- •- acute phase of intestinal insufficiency (less than 28 days after resection)
- •- intravenous substitution of macronutrients (glucose, amino acids or lipids (intestinal insufficiency)
- •- intramuscular substitution of micronutrients is allowed (e.g. vitamin B12)
- •- uncontrolled underlying disease leading to SBS (e.g. active Crohn's disease)
- •CONTROL PATIENTS:
- •- major underlying and concomitant diseases
- •- food allergies
- •HEALTHY CONTROLS:
- •- tumor diseases in the past 5 years
- •- medically diagnosed, serious chronic diseases or changes in the gastrointestinal tract that may affect the absorption of nutrients (e.g. celiac disease, chronic inflammatory bowel disease or irritable bowel syndrome diagnosed according to Rome IV criteria, relevant bowel resections including short bowel syndrome)
- •- rheumatic diseases requiring permanent drug therapy (rheumatoid arthritis, fibromyalgia)
- •- chronic use of anti-inflammatory or pain-relieving drugs or use of anti-inflammatory or pain-relieving drugs for more than 3 days in the last 3 weeks
- •- average daily alcohol consumption > 20 g in women and > 30 g in men
- •- diagnosed severe liver disease requiring medical attention and drug therapy (liver cirrhosis, NASH / ASH, hepatitides)
- •- acute or chronic pancreatitis
- •- acute and chronic renal failure
- •- myocardial infarction or cerebral insult within 6 months prior to examination
- •- coronary artery disease/pAVK
- •- heart failure with stages 3 and 4 according to NYHA classification
- •- severe chronic pulmonary disease (COPD)
- •- history of significant neurological or psychiatric diseases (including epilepsy, bipolar disorders, dementia and neuromuscular diseases)
- •- presence of pareses including mono- and diparesis
- •- rare congenital metabolic diseases (cystic fibrosis, phenylketonuria)
- •- expected altered body composition (extreme sports activity < 2h/day), edema, amputation of the extremities (arm and/or leg)
- •- highly atypical or restrictive dietary choices/concepts followed voluntarily (macrobiotics, paleo-diet, Atkins diet, Mayo diet, insticto diets) or due to food intolerances/allergies
- •- simultaneous participation in other studies associated with drug use and potentially having a significant impact on body composition or dietary behaviour
Investigators
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