Skip to main content
OpenTrials
Completed

NCT Number: NCT04474743

Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver Cirrhoses Chronic Disease Chronic Pancreatitis Digestive System Diseases Disease Attributes Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Short Bowel Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medicine Greifswald, Greifswald, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no intervention - cross-sectional observational only

Other

No intervention - cross-sectional observational only

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. Hemoglobin

    Time frame: Baseline

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

  21. Hematocrit

    Time frame: Baseline

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

  22. Mean Corpuscular Volume

    Time frame: Baseline

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

  23. 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

  24. Reticulocyte Count

    Time frame: Baseline

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

  25. Sodium

    Time frame: Baseline

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

  26. Potassium

    Time frame: Baseline

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

  27. Calcium

    Time frame: Baseline

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

  28. Magnesium

    Time frame: Baseline

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

  29. Phosphate

    Time frame: Baseline

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

  30. Aspartate Transaminase

    Time frame: Baseline

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

  31. Alanine Aminotransferase

    Time frame: Baseline

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

  32. 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

  33. Alkaline Phosphatase

    Time frame: Baseline

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

  34. Bilirubin

    Time frame: Baseline

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

  35. 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

  36. 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

  37. Interleukin-6

    Time frame: Baseline

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

  38. 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

  39. Albumin

    Time frame: Baseline

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

  40. Creatinine

    Time frame: Baseline

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

  41. Urea

    Time frame: Baseline

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

  42. Uric Acid

    Time frame: Baseline

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

  43. Glucose

    Time frame: Baseline

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

  44. Glycated hemoglobin

    Time frame: Baseline

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

  45. Insulin

    Time frame: Baseline

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

  46. Total Cholesterol

    Time frame: Baseline

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

  47. 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

  48. 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

  49. Triglycerides

    Time frame: Baseline

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

  50. 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

  51. Zinc

    Time frame: Baseline

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

  52. Iron

    Time frame: Baseline

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

  53. 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

  54. 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)

  55. 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)

Secondary outcomes

  1. 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.

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Leibniz Institute for Farm Animal Biology (FBN)
  • University Medical Center Rostock
  • University of Applied Sciences Neubrandenburg

Registry information

Official study 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))

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 17, 2020
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.