Liver CirrhosesNCT04474743
Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study
An observational study of Liver Cirrhoses and Chronic Pancreatitis, run by University Medicine Greifswald at 3 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhoses, Chronic Pancreatitis, Short Bowel Syndrome
- How many people
- 345 participants
- Where
- 3 sitesGermany
- Study dates
- 2 Oct 2018to 13 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients eligible for study participation will be recruited at the University hospitals in the cities of Rostock and Greifswald (Northeast Germany). Hospitalized as well outcare-patients will be considered for recruitment. Healthy controls will be recruited from the general public in the city of Neubrandenburg (Northeast Germany).
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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)
Show all 49Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Medicine Greifswald
Greifswald, 17475
University of Applied Sciences Neubrandenburg
Neubrandenburg, 17033
Univeristy Medicine Rostock
Rostock, 18057
About this study
Official title: 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.
Read the detailed description
Malnutrition and sarcopenia are consequences of life-threatening gastroenterological diseases such as liver cirrhosis, chronic pancreatitis and short bowel syndrome and are associated with a poorer clinical outcome and a reduced quality of life. The diagnostic criteria of both conditions differ, as do the consequences for adequate nutritional therapy. Nevertheless, malnutrition and sarcopenia are often discussed in confusion in the literature. In addition, the underlying mechanisms of malnutrition and sarcopenia can differ in the various diseases. The aim of the study is to compare nutrition-associated parameters from patients with liver cirrhosis, chronic pancreatitis and short bowel syndrome, to characterize the disease-specific phenotype of malnutrition and sarcopenia of the examined diseases and to obtain information on mechanistic relationships. The pathophysiological understanding of the clinical settings as well as the development of malnutrition and sarcopenia is important for choosing specific nutritional therapies. For this, malnourished and non-malnourished patients of each examined disease are compared with controls from patients with non-specific, abdominal symptoms and healthy control subjects. Data on food intake, physical activity, body composition and anthropometry as well as muscle strength and muscle function are recorded. Clinical and chemical blood parameters, the plasma metabolome as well as transport and barrier proteins of the intestine are also examined.
- Conditions
- Liver Cirrhoses, Chronic Pancreatitis, Short Bowel Syndrome
- Being tested
- No intervention - cross-sectional observational only
- Medical subject headings
- Pancreatitis, Chronic, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - cross-sectional observational onlyOther
No intervention - cross-sectional observational only
| Study group | Role | What they receive |
|---|---|---|
| Liver Cirrhosis | Patients diagnosed with liver cirrhosis. Receives: Other: No intervention - cross-sectional observational only | |
| Chronic Pancreatitis | Patients diagnosed with chronic pancreatitis. Receives: Other: No intervention - cross-sectional observational only | |
| Short Bowel Syndrome | Patients diagnosed with short bowel Syndrome. Receives: Other: No intervention - cross-sectional observational only | |
| Control Patients | Otherwise healthy patients visiting hospital with other non-severe diseases. Receives: Other: No intervention - cross-sectional observational only | |
| Healthy Controls | Healthy subjects recruited from the general population. Receives: Other: No intervention - cross-sectional observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sarcopenia
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
Measured: Baseline
Quantitative Food Intake
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
Measured: Baseline
Qualitative Food Intake
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
Measured: Baseline
Physical Activity
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
Measured: Baseline
Body Weight
Determination of body weight measured in kilograms in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
Measured: Baseline
Height
Determination of height measured in meters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
Measured: Baseline
Body Mass Index
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
Measured: Baseline
Waist Circumference
Determination of waist circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
Measured: Baseline
Hip Circumference
Determination of hip circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
Measured: Baseline
Waist-to-Hip Ratio
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
Measured: Baseline
Upper Arm Circumference
Determination of upper arm circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
Measured: Baseline
Triceps Skinfold Thickness
Determination of triceps skinfold thickness measured in millimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects
Measured: Baseline
Fat Free Mass
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
Measured: Baseline
Skeletal Muscle Mass
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
Measured: Baseline
Fat Mass
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
Measured: Baseline
Total Body Water
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
Measured: Baseline
Extracellular Water
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
Measured: Baseline
Phase Angle
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
Measured: Baseline
Muscle Strength
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
Measured: Baseline
Hemoglobin
Determination of hemoglobin level in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Hematocrit
Determination of hematocrit level in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Mean Corpuscular Volume
Determination of mean corpuscular volume in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Mean Corpuscular Hemoglobin Concentration
Determination of mean corpuscular hemoglobin concentration in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Reticulocyte Count
Determination of reticulocyte count in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Sodium
Determination of plasma concentration of sodium in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Potassium
Determination of plasma concentration of potassium in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Calcium
Determination of plasma concentration of calcium in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Magnesium
Determination of plasma concentration of magnesium in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Phosphate
Determination of plasma concentration of phosphate in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Aspartate Transaminase
Determination of plasma concentration of aspartate transferase in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Alanine Aminotransferase
Determination of plasma concentration of alanine aminotransferase in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Gamma-glutamyl Transferase
Determination of plasma concentration of gamma-glutamyl transferase in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Alkaline Phosphatase
Determination of plasma concentration of alkaline phosphatase in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Bilirubin
Determination of plasma concentration of bilirubin in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
C-reactive Protein
Determination of plasma concentration of C-reactive protein in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Interleukin-1 Beta
Determination of serum concentration of interleukin-1 beta in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Interleukin-6
Determination of plasma concentration of interleukin-6 in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Tumor Necrosis Factor Alpha
Determination of serum concentration of tumor necrosis factor alpha in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Albumin
Determination of plasma concentration of albumin in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Creatinine
Determination of plasma concentration of creatinine in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Urea
Determination of plasma concentration of urea in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Uric Acid
Determination of plasma concentration of uric acid in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Glucose
Determination of plasma concentration of glucose in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Glycated hemoglobin
Determination of plasma concentration of glycated hemoglobin in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Insulin
Determination of plasma concentration of insulin in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Total Cholesterol
Determination of plasma concentration of total cholesterol in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
High-density Lipoprotein Cholesterol
Determination of plasma concentration of high-density lipoprotein cholesterol in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Low-density Lipoprotein Cholesterol
Determination of plasma concentration of low-density lipoprotein cholesterol in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Triglycerides
Determination of plasma concentration of triglycerides in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Non-essential Fatty Acids
Determination of plasma concentration of non-essential fatty acids in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Zinc
Determination of serum concentration of zinc in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Iron
Determination of plasma concentration of iron in comparison to control patients and in comparison to healthy control subjects
Measured: Baseline
Plasma Metabolome
In a participants subgroup, investigations of the plasma metabolome in comparison with control patients and in comparison with healthy control subjects
Measured: Baseline
Intestinal Barrier Function
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)
Measured: Baseline
Expression of Intestinal Ion Transporters
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)
Measured: Baseline
Secondary outcomes (3)
Malnutrition-Sarcopenia Score
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.
Measured: Baseline
Validity of the Study of Health in Pomerania Food Frequency Questionnaire
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)
Measured: Baseline
Factor Analysis of Phenotypes of Sarcopenia and Malnutrition
Determination of parameters characterizing phenotypes of sarcopenia and malnutrition in the investigated gastroenterological disease (liver cirrhosis, chronic pancreatitis, short bowel syndrome) by factor analysis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start2 Oct 2018
- Primary completion13 Sep 2021
- Study completion13 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Rostock, University of Applied Sciences Neubrandenburg, Leibniz Institute for Farm Animal Biology (FBN)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med. Lamprecht, Principal investigator, University Medical Center Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474743
- Sponsor's protocol ID
- A 2018-0129
- Status last verified
- Nov 2021
- First submitted
- 29 Jun 2020
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35719155
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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))
- ClinicalTrials.gov ID
- NCT04474743
- Acronym / sponsor ID
- A 2018-0129
- Conditions
- Liver Cirrhoses, Chronic Pancreatitis, Short Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- University Medical Center Rostock, University of Applied Sciences Neubrandenburg, Leibniz Institute for Farm Animal Biology (FBN)
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Malnutrition and sarcopenia are consequences of life-threatening gastroenterological diseases such as liver cirrhosis, chronic pancreatitis and short bowel syndrome and are associated with a poorer clinical outcome and a reduced quality of life. The diagnostic criteria of both conditions differ, as do the consequences for adequate nutritional therapy. Nevertheless, malnutrition and sarcopenia are often discussed in confusion in the literature. In addition, the underlying mechanisms of malnutrition and sarcopenia can differ in the various diseases. The aim of the study is to compare nutrition-associated parameters from patients with liver cirrhosis, chronic pancreatitis and short bowel syndrome, to characterize the disease-specific phenotype of malnutrition and sarcopenia of the examined diseases and to obtain information on mechanistic relationships. The pathophysiological understanding of the clinical settings as well as the development of malnutrition and sarcopenia is important for choosing specific nutritional therapies. For this, malnourished and non-malnourished patients of each examined disease are compared with controls from patients with non-specific, abdominal symptoms and healthy control subjects. Data on food intake, physical activity, body composition and anthropometry as well as muscle strength and muscle function are recorded. Clinical and chemical blood parameters, the plasma metabolome as well as transport and barrier proteins of the intestine are also examined.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Liver Cirrhosis | – | Other: No intervention - cross-sectional observational onlyPatients diagnosed with liver cirrhosis. |
| Chronic Pancreatitis | – | Other: No intervention - cross-sectional observational onlyPatients diagnosed with chronic pancreatitis. |
| Short Bowel Syndrome | – | Other: No intervention - cross-sectional observational onlyPatients diagnosed with short bowel Syndrome. |
| Control Patients | – | Other: No intervention - cross-sectional observational onlyOtherwise healthy patients visiting hospital with other non-severe diseases. |
| Healthy Controls | – | Other: No intervention - cross-sectional observational onlyHealthy subjects recruited from the general population. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for study participation will be recruited at the University hospitals in the cities of Rostock and Greifswald (Northeast Germany). Hospitalized as well outcare-patients will be considered for recruitment. Healthy controls will be recruited from the general public in the city of Neubrandenburg (Northeast Germany).
Key inclusion criteria (16 listed)
- 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
- 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
Key exclusion criteria (49 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - cross-sectional observational onlyNo intervention - cross-sectional observational only | Other | Chronic Pancreatitis, Control Patients, Healthy Controls, Liver Cirrhosis, Short Bowel Syndrome |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Hemoglobin
Time frame: Baseline
Determination of hemoglobin level in comparison to control patients and in comparison to healthy control subjects
Hematocrit
Time frame: Baseline
Determination of hematocrit level in comparison to control patients and in comparison to healthy control subjects
Mean Corpuscular Volume
Time frame: Baseline
Determination of mean corpuscular volume in comparison to control patients and in comparison to healthy control subjects
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
Reticulocyte Count
Time frame: Baseline
Determination of reticulocyte count in comparison to control patients and in comparison to healthy control subjects
Sodium
Time frame: Baseline
Determination of plasma concentration of sodium in comparison to control patients and in comparison to healthy control subjects
Potassium
Time frame: Baseline
Determination of plasma concentration of potassium in comparison to control patients and in comparison to healthy control subjects
Calcium
Time frame: Baseline
Determination of plasma concentration of calcium in comparison to control patients and in comparison to healthy control subjects
Magnesium
Time frame: Baseline
Determination of plasma concentration of magnesium in comparison to control patients and in comparison to healthy control subjects
Phosphate
Time frame: Baseline
Determination of plasma concentration of phosphate in comparison to control patients and in comparison to healthy control subjects
Aspartate Transaminase
Time frame: Baseline
Determination of plasma concentration of aspartate transferase in comparison to control patients and in comparison to healthy control subjects
Alanine Aminotransferase
Time frame: Baseline
Determination of plasma concentration of alanine aminotransferase in comparison to control patients and in comparison to healthy control subjects
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
Alkaline Phosphatase
Time frame: Baseline
Determination of plasma concentration of alkaline phosphatase in comparison to control patients and in comparison to healthy control subjects
Bilirubin
Time frame: Baseline
Determination of plasma concentration of bilirubin in comparison to control patients and in comparison to healthy control subjects
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
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
Interleukin-6
Time frame: Baseline
Determination of plasma concentration of interleukin-6 in comparison to control patients and in comparison to healthy control subjects
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
Albumin
Time frame: Baseline
Determination of plasma concentration of albumin in comparison to control patients and in comparison to healthy control subjects
Creatinine
Time frame: Baseline
Determination of plasma concentration of creatinine in comparison to control patients and in comparison to healthy control subjects
Urea
Time frame: Baseline
Determination of plasma concentration of urea in comparison to control patients and in comparison to healthy control subjects
Uric Acid
Time frame: Baseline
Determination of plasma concentration of uric acid in comparison to control patients and in comparison to healthy control subjects
Glucose
Time frame: Baseline
Determination of plasma concentration of glucose in comparison to control patients and in comparison to healthy control subjects
Glycated hemoglobin
Time frame: Baseline
Determination of plasma concentration of glycated hemoglobin in comparison to control patients and in comparison to healthy control subjects
Insulin
Time frame: Baseline
Determination of plasma concentration of insulin in comparison to control patients and in comparison to healthy control subjects
Total Cholesterol
Time frame: Baseline
Determination of plasma concentration of total cholesterol in comparison to control patients and in comparison to healthy control subjects
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
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
Triglycerides
Time frame: Baseline
Determination of plasma concentration of triglycerides in comparison to control patients and in comparison to healthy control subjects
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
Zinc
Time frame: Baseline
Determination of serum concentration of zinc in comparison to control patients and in comparison to healthy control subjects
Iron
Time frame: Baseline
Determination of plasma concentration of iron in comparison to control patients and in comparison to healthy control subjects
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
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)
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)
3 secondary outcomes
Malnutrition-Sarcopenia Score
Time frame: Baseline
Validity of the Study of Health in Pomerania Food Frequency Questionnaire
Time frame: Baseline
Factor Analysis of Phenotypes of Sarcopenia and Malnutrition
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Derived from this study: PubMed 35719155Wiese 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. med. Lamprecht principal investigator
University Medical Center Rostock
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhoses and Chronic Pancreatitis, run by University Medicine Greifswald at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sarcopenia (time frame: Baseline). The study lists 55 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04474743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.