Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study
NCT ID: NCT04474743
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
345 participants
OBSERVATIONAL
2018-10-02
2021-09-13
Brief Summary
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For this, malnourished and non-malnourished patients of the different diseases are compared with controls patients with non-specific complaints of the gastrointestinal tract as well as with healthy study participants.
Data on food intake, physical activity, body composition and body measurements as well as muscle strength and muscle function are recorded. Blood values as well as transport and barrier properties of the intestine will also be examined.
Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Liver Cirrhosis
Patients diagnosed with liver cirrhosis.
No intervention - cross-sectional observational only
No intervention - cross-sectional observational only
Chronic Pancreatitis
Patients diagnosed with chronic pancreatitis.
No intervention - cross-sectional observational only
No intervention - cross-sectional observational only
Short Bowel Syndrome
Patients diagnosed with short bowel Syndrome.
No intervention - cross-sectional observational only
No intervention - cross-sectional observational only
Control Patients
Otherwise healthy patients visiting hospital with other non-severe diseases.
No intervention - cross-sectional observational only
No intervention - cross-sectional observational only
Healthy Controls
Healthy subjects recruited from the general population.
No intervention - cross-sectional observational only
No intervention - cross-sectional observational only
Interventions
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No intervention - cross-sectional observational only
No intervention - cross-sectional observational only
Eligibility Criteria
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Inclusion Criteria
* based on clinical and imaging criteria (sonography or computed tomography (CT) or magnetic resonance imaging (MRI)) without evidence of hepatocellular carcinoma
* Child-Pugh Stadium A-C
Chronic Pancreatitis:
* based on imaging criteria (endoscopic ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), magnetic resonance cholangiopancreatography (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
Short Bowel Syndrome (SBS):
\- 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
* negative Nutritional Risk Screening (NRS-2002 \< 3)
* gastroscopy without clinically relevant result (mild gastritis aspect, small axial hernia, typical glandular cysts, typical brunneromas can be included)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
* pacemaker or implanted defibrillator
* pregnancy or lactation
* lack of ability to answer the questionnaires
* taking certain medications during the previous 4 weeks (protein pump inhibitors and H2 antagonists, except medication on demand or ≤ 4 weeks continuously, antibiotics, narcotics, non-opioid analgesics except medication on demand (≤ 1 day/week), anticholinergics, antidepressants, motility drugs (metoclopramide, motilium, bromocriptine, prucalopride), thyroid drugs except stable thyroid hormone substitution with euthyroid metabolism, steroids, immunomodulators, anti-inflammatory biologics)
Subsequent Exclusion of Control Patients:
* if, contrary to expectations, malnutrition is diagnosed in spite of an inconspicuous NRS-2002 within the framework of the study
* as well as in the case of relevant, conspicuous esophago-gastro-duodenoscopy findings
Liver Cirrhosis:
* steatohepatitis according to clinical or laboratory parameters
* acute alcoholic hepatitis according to clinical and imaging parameters (sonography, CT, MRI)
* existing transjugular intrahepatic portosystemic shunt (TIPS)
* known hepatocellular carcinoma (HCC)
* state after liver transplantation
Chronic Pancreatitis:
* acute pancreatitis
* extrapancreatic infection
* coexisting liver cirrhosis based on clinical and imaging parameters
* 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 (SBS):
* acute phase of intestinal insufficiency (less than 28 days after resection)
* intravenous substitution of macronutrients (water, electrolytes, 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, non-alcoholic steatohepatitis (NASH) / alcoholic steatohepatitis (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 (peripheral artery disease (PAD))
* heart failure with stages 3 and 4 according to NYHA (New York Heart Association) 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, instinctive 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
18 Years
ALL
Yes
Sponsors
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University Medical Center Rostock
OTHER
University of Applied Sciences Neubrandenburg
OTHER
Leibniz Institute for Farm Animal Biology (FBN)
UNKNOWN
University Medicine Greifswald
OTHER
Responsible Party
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Principal Investigators
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Prof. Dr. med. Lamprecht
Role: PRINCIPAL_INVESTIGATOR
University Medicine Rostock
Locations
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University Medicine Greifswald
Greifswald, , Germany
University of Applied Sciences Neubrandenburg
Neubrandenburg, , Germany
Univeristy Medicine Rostock
Rostock, , Germany
Countries
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References
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Wiese ML, Gartner S, von Essen N, Doller J, Frost F, Tran QT, Weiss FU, Meyer F, Valentini L, Garbe LA, Metges CC, Bannert K, Sautter LF, Ehlers L, Jaster R, Lamprecht G, Steveling A, Lerch MM, Aghdassi AA. Malnutrition Is Highly Prevalent in Patients With Chronic Pancreatitis and Characterized by Loss of Skeletal Muscle Mass but Absence of Impaired Physical Function. Front Nutr. 2022 Jun 1;9:889489. doi: 10.3389/fnut.2022.889489. eCollection 2022.
Other Identifiers
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A 2018-0129
Identifier Type: -
Identifier Source: org_study_id