- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04474743
Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study
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))
Malnutrition and muscle wasting are common consequences of life-threatening, chronic diseases of the gastrointestinal tract. Such diseases include liver cirrhosis, chronic pancreatitis and short bowel syndrome. Malnutrition and muscle wasting increase the risk of complications, reduce the life expectancy and impair the quality of life. The development of malnutrition and muscle wasting is different, as is the diagnosis and nutritional treatment. There are also different mechanisms of origin for the underlying diseases. The aim of the study is to compare data related to nutrition and physical condition of patients with liver cirrhosis, chronic pancreatitis and short bowel syndrome. Malnutrition and muscle wasting within the specific diseases will be characterized and possible correlations will be identified.
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Greifswald, Germany, 17475
- University Medicine Greifswald
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Neubrandenburg, Germany, 17033
- University of Applied Sciences Neubrandenburg
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Rostock, Germany, 18057
- Univeristy Medicine Rostock
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Liver Cirrhosis:
- 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:
General Exclusion Criteria:
- parenteral nutrition in the previous 6 months
- 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
Specific Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Liver Cirrhosis
Patients diagnosed with liver cirrhosis.
|
No intervention - cross-sectional observational only
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Chronic Pancreatitis
Patients diagnosed with chronic pancreatitis.
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No intervention - cross-sectional observational only
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Short Bowel Syndrome
Patients diagnosed with short bowel Syndrome.
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No intervention - cross-sectional observational only
|
Control Patients
Otherwise healthy patients visiting hospital with other non-severe diseases.
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No intervention - cross-sectional observational only
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Healthy Controls
Healthy subjects recruited from the general population.
|
No intervention - cross-sectional observational only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sarcopenia
Time Frame: Baseline
|
Descriptive and inferential determination of the prevalence of sarcopenia according to the European Working Group on Sarcopenia in Older People 2 criteria (EWGSOP2 criteria) in malnourished and non malnourished patients with liver cirrhosis, chronic pancreatitis or short bowel syndrome - as a total group and separated by type of disease
|
Baseline
|
Quantitative Food Intake
Time Frame: Baseline
|
Determination of quantitative food intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Qualitative Food Intake
Time Frame: Baseline
|
Determination of qualitative food intake assessed by the Study of Health in Pomerania Food Frequency Questionnaire (SHIP-FFQ) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Physical Activity
Time Frame: Baseline
|
Determination of physical activity assessed by the International Physical Activity Questionnaire (IPAQ) Short Form in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Body Weight
Time Frame: Baseline
|
Determination of body weight measured in kilograms in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Height
Time Frame: Baseline
|
Determination of height measured in meters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Body Mass Index
Time Frame: Baseline
|
Determination of body mass index in kg/m^2 (calculated from the values obtained for body weight and height) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Waist Circumference
Time Frame: Baseline
|
Determination of waist circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Hip Circumference
Time Frame: Baseline
|
Determination of hip circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Waist-to-Hip Ratio
Time Frame: Baseline
|
Determination of waist-to-hip ratio (calculated from the values obtained for waist and hip circumference) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Upper Arm Circumference
Time Frame: Baseline
|
Determination of upper arm circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Triceps Skinfold Thickness
Time Frame: Baseline
|
Determination of triceps skinfold thickness measured in millimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Fat Free Mass
Time Frame: Baseline
|
Determination of fat free mass measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Skeletal Muscle Mass
Time Frame: Baseline
|
Determination of skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Fat Mass
Time Frame: Baseline
|
Determination of fat mass measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Total Body Water
Time Frame: Baseline
|
Determination of total body water measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Extracellular Water
Time Frame: Baseline
|
Determination of extracellular water measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Phase Angle
Time Frame: Baseline
|
Determination of phase angle measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Muscle Strength
Time Frame: Baseline
|
Determination of muscle strength measured by a handgrip strength dynamometer in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
|
Baseline
|
Hemoglobin
Time Frame: Baseline
|
Determination of hemoglobin level in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Hematocrit
Time Frame: Baseline
|
Determination of hematocrit level in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Mean Corpuscular Volume
Time Frame: Baseline
|
Determination of mean corpuscular volume in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Mean Corpuscular Hemoglobin Concentration
Time Frame: Baseline
|
Determination of mean corpuscular hemoglobin concentration in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Reticulocyte Count
Time Frame: Baseline
|
Determination of reticulocyte count in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Sodium
Time Frame: Baseline
|
Determination of plasma concentration of sodium in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Potassium
Time Frame: Baseline
|
Determination of plasma concentration of potassium in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Calcium
Time Frame: Baseline
|
Determination of plasma concentration of calcium in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Magnesium
Time Frame: Baseline
|
Determination of plasma concentration of magnesium in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Phosphate
Time Frame: Baseline
|
Determination of plasma concentration of phosphate in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Aspartate Transaminase
Time Frame: Baseline
|
Determination of plasma concentration of aspartate transferase in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Alanine Aminotransferase
Time Frame: Baseline
|
Determination of plasma concentration of alanine aminotransferase in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Gamma-glutamyl Transferase
Time Frame: Baseline
|
Determination of plasma concentration of gamma-glutamyl transferase in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Alkaline Phosphatase
Time Frame: Baseline
|
Determination of plasma concentration of alkaline phosphatase in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Bilirubin
Time Frame: Baseline
|
Determination of plasma concentration of bilirubin in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
C-reactive Protein
Time Frame: Baseline
|
Determination of plasma concentration of C-reactive protein in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Interleukin-1 Beta
Time Frame: Baseline
|
Determination of serum concentration of interleukin-1 beta in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Interleukin-6
Time Frame: Baseline
|
Determination of plasma concentration of interleukin-6 in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Tumor Necrosis Factor Alpha
Time Frame: Baseline
|
Determination of serum concentration of tumor necrosis factor alpha in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Albumin
Time Frame: Baseline
|
Determination of plasma concentration of albumin in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Creatinine
Time Frame: Baseline
|
Determination of plasma concentration of creatinine in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Urea
Time Frame: Baseline
|
Determination of plasma concentration of urea in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Uric Acid
Time Frame: Baseline
|
Determination of plasma concentration of uric acid in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Glucose
Time Frame: Baseline
|
Determination of plasma concentration of glucose in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Glycated hemoglobin
Time Frame: Baseline
|
Determination of plasma concentration of glycated hemoglobin in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Insulin
Time Frame: Baseline
|
Determination of plasma concentration of insulin in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Total Cholesterol
Time Frame: Baseline
|
Determination of plasma concentration of total cholesterol in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
High-density Lipoprotein Cholesterol
Time Frame: Baseline
|
Determination of plasma concentration of high-density lipoprotein cholesterol in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Low-density Lipoprotein Cholesterol
Time Frame: Baseline
|
Determination of plasma concentration of low-density lipoprotein cholesterol in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Triglycerides
Time Frame: Baseline
|
Determination of plasma concentration of triglycerides in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Non-essential Fatty Acids
Time Frame: Baseline
|
Determination of plasma concentration of non-essential fatty acids in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Zinc
Time Frame: Baseline
|
Determination of serum concentration of zinc in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Iron
Time Frame: Baseline
|
Determination of plasma concentration of iron in comparison to control patients and in comparison to healthy control subjects
|
Baseline
|
Plasma Metabolome
Time Frame: Baseline
|
In a participants subgroup, investigations of the plasma metabolome in comparison with control patients and in comparison with healthy control subjects
|
Baseline
|
Intestinal Barrier Function
Time Frame: Baseline
|
Determination of the intestinal barrier function in a patient subgroup in comparison to control patients (using proximal small intestinal biopsies, qRT-PCR (Real Time Polymerase Chain Reaction) of different intestinal barrier markers)
|
Baseline
|
Expression of Intestinal Ion Transporters
Time Frame: Baseline
|
Determination of the expression of intestinal ion transporters in a patient subgroup in comparison to control patients (using proximal small intestinal biopsies, qRT-PCR (Real Time Polymerase Chain Reaction) of different intestinal transport markers)
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Malnutrition-Sarcopenia Score
Time Frame: Baseline
|
Correlative, factorial or other presentation of the results including statistical-mathematical argumentation of the usefulness of a combined malnutrition-sarcopenia score (MaSa score) for practical application.
|
Baseline
|
Validity of the Study of Health in Pomerania Food Frequency Questionnaire
Time Frame: Baseline
|
Determination of the validity of the Study of Health in Pomerania Food Frequency Questionnaire (SHIP-FFQ) by assessment of percent agreement with the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)
|
Baseline
|
Factor Analysis of Phenotypes of Sarcopenia and Malnutrition
Time Frame: Baseline
|
Determination of parameters characterizing phenotypes of sarcopenia and malnutrition in the investigated gastroenterological disease (liver cirrhosis, chronic pancreatitis, short bowel syndrome) by factor analysis
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Prof. Dr. med. Lamprecht, University Medicine Rostock
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Postoperative Complications
- Disease
- Gastrointestinal Diseases
- Liver Diseases
- Nutrition Disorders
- Intestinal Diseases
- Malabsorption Syndromes
- Pancreatic Diseases
- Fibrosis
- Syndrome
- Liver Cirrhosis
- Malnutrition
- Pancreatitis
- Pancreatitis, Chronic
- Short Bowel Syndrome
Other Study ID Numbers
- A 2018-0129
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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