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CompletedNCT04474743Updated Nov 2, 2021

Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study

An observational study in Liver Cirrhoses, Chronic Pancreatitis and Short Bowel Syndrome, sponsored by University Medicine Greifswald. Completed at 3 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-02.

Sponsored by University Medicine Greifswald · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
345
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Liver Cirrhoses
  • Chronic Pancreatitis
  • Short Bowel Syndrome
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 345 is above the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

University Medicine Greifswald is the lead sponsor of 149 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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).

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

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
345 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Liver Cirrhosis

    Patients diagnosed with liver cirrhosis.

    Other: No intervention - cross-sectional observational only

  • Chronic Pancreatitis

    Patients diagnosed with chronic pancreatitis.

    Other: No intervention - cross-sectional observational only

  • Short Bowel Syndrome

    Patients diagnosed with short bowel Syndrome.

    Other: No intervention - cross-sectional observational only

  • Control Patients

    Otherwise healthy patients visiting hospital with other non-severe diseases.

    Other: No intervention - cross-sectional observational only

  • Healthy Controls

    Healthy subjects recruited from the general population.

    Other: No intervention - cross-sectional observational only

Interventions

  • OtherNo intervention - cross-sectional observational only

    No intervention - cross-sectional observational only

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

  2. 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

    Time frame: Baseline

  3. 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

    Time frame: Baseline

  4. 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

    Time frame: Baseline

  5. 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

    Time frame: Baseline

  6. Height

    Determination of height measured in meters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

    Time frame: Baseline

  7. 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

    Time frame: Baseline

  8. 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

    Time frame: Baseline

  9. 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

    Time frame: Baseline

  10. 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

    Time frame: Baseline

  11. 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

    Time frame: Baseline

  12. 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

    Time frame: Baseline

  13. 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

    Time frame: Baseline

  14. 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

    Time frame: Baseline

  15. 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

    Time frame: Baseline

  16. 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

    Time frame: Baseline

  17. 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

    Time frame: Baseline

  18. 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

    Time frame: Baseline

  19. 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

    Time frame: Baseline

  20. Hemoglobin

    Determination of hemoglobin level in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  21. Hematocrit

    Determination of hematocrit level in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  22. Mean Corpuscular Volume

    Determination of mean corpuscular volume in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  23. Mean Corpuscular Hemoglobin Concentration

    Determination of mean corpuscular hemoglobin concentration in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  24. Reticulocyte Count

    Determination of reticulocyte count in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  25. Sodium

    Determination of plasma concentration of sodium in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  26. Potassium

    Determination of plasma concentration of potassium in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  27. Calcium

    Determination of plasma concentration of calcium in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  28. Magnesium

    Determination of plasma concentration of magnesium in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  29. Phosphate

    Determination of plasma concentration of phosphate in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  30. Aspartate Transaminase

    Determination of plasma concentration of aspartate transferase in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  31. Alanine Aminotransferase

    Determination of plasma concentration of alanine aminotransferase in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  32. Gamma-glutamyl Transferase

    Determination of plasma concentration of gamma-glutamyl transferase in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  33. Alkaline Phosphatase

    Determination of plasma concentration of alkaline phosphatase in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  34. Bilirubin

    Determination of plasma concentration of bilirubin in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  35. C-reactive Protein

    Determination of plasma concentration of C-reactive protein in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  36. Interleukin-1 Beta

    Determination of serum concentration of interleukin-1 beta in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  37. Interleukin-6

    Determination of plasma concentration of interleukin-6 in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  38. 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

    Time frame: Baseline

  39. Albumin

    Determination of plasma concentration of albumin in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  40. Creatinine

    Determination of plasma concentration of creatinine in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  41. Urea

    Determination of plasma concentration of urea in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  42. Uric Acid

    Determination of plasma concentration of uric acid in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  43. Glucose

    Determination of plasma concentration of glucose in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  44. Glycated hemoglobin

    Determination of plasma concentration of glycated hemoglobin in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  45. Insulin

    Determination of plasma concentration of insulin in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  46. Total Cholesterol

    Determination of plasma concentration of total cholesterol in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  47. 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

    Time frame: Baseline

  48. 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

    Time frame: Baseline

  49. Triglycerides

    Determination of plasma concentration of triglycerides in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  50. 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

    Time frame: Baseline

  51. Zinc

    Determination of serum concentration of zinc in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  52. Iron

    Determination of plasma concentration of iron in comparison to control patients and in comparison to healthy control subjects

    Time frame: Baseline

  53. Plasma Metabolome

    In a participants subgroup, investigations of the plasma metabolome in comparison with control patients and in comparison with healthy control subjects

    Time frame: Baseline

  54. 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)

    Time frame: Baseline

  55. 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)

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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)

    Time frame: Baseline

  3. 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

    Time frame: Baseline

07

Study locations

3 sites
  • University Medicine Greifswald
    Greifswald, 17475, Germany
  • University of Applied Sciences Neubrandenburg
    Neubrandenburg, 17033, Germany
  • Univeristy Medicine Rostock
    Rostock, 18057, Germany
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04474743
Lead sponsor
University Medicine Greifswald
Collaborators
University Medical Center Rostock, University of Applied Sciences Neubrandenburg, Leibniz Institute for Farm Animal Biology (FBN)
Responsible party
Sponsor
First posted
Jul 17, 2020
Start date
Oct 2, 2018
Primary completion
Sep 13, 2021
Completion
Sep 13, 2021
Last update
Nov 2, 2021

Study contacts

Prof. Dr. med. Lamprecht
principal investigator · University Medicine Rostock

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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