Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study

NCT04474743 | Completed

• 1 other identifier: A 2018-0129
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Liver Cirrhoses; Chronic Pancreatitis; Short Bowel Syndrome

Outcome Measures

Primary Outcomes (55)

• 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

  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

  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

  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

  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

  Baseline

• Height

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

  Baseline

• Body Mass Index

  Determination of body mass index in kg/m\^2 (calculated from the values obtained for body weight and height) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Waist Circumference

  Determination of waist circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Hip Circumference

  Determination of hip circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Waist-to-Hip Ratio

  Determination of waist-to-hip ratio (calculated from the values obtained for waist and hip circumference) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Upper Arm Circumference

  Determination of upper arm circumference measured in centimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Triceps Skinfold Thickness

  Determination of triceps skinfold thickness measured in millimeters in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Fat Free Mass

  Determination of fat free mass measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Skeletal Muscle Mass

  Determination of skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Fat Mass

  Determination of fat mass measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Total Body Water

  Determination of total body water measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Extracellular Water

  Determination of extracellular water measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Phase Angle

  Determination of phase angle measured by Bioelectrical Impedance Analysis (BIA) in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Muscle Strength

  Determination of muscle strength measured by a handgrip strength dynamometer in comparison with non malnourished and non-sarcopenia patients and in comparison with healthy control subjects

  Baseline

• Hemoglobin

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

  Baseline

• Hematocrit

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

  Baseline

• Mean Corpuscular Volume

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

  Baseline

• Mean Corpuscular Hemoglobin Concentration

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

  Baseline

• Reticulocyte Count

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

  Baseline

• Sodium

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

  Baseline

• Potassium

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

  Baseline

• Calcium

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

  Baseline

• Magnesium

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

  Baseline

• Phosphate

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

  Baseline

• Aspartate Transaminase

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

  Baseline

• Alanine Aminotransferase

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

  Baseline

• Gamma-glutamyl Transferase

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

  Baseline

• Alkaline Phosphatase

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

  Baseline

• Bilirubin

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

  Baseline

• C-reactive Protein

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

  Baseline

• Interleukin-1 Beta

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

  Baseline

• Interleukin-6

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

  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

  Baseline

• Albumin

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

  Baseline

• Creatinine

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

  Baseline

• Urea

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

  Baseline

• Uric Acid

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

  Baseline

• Glucose

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

  Baseline

• Glycated hemoglobin

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

  Baseline

• Insulin

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

  Baseline

• Total Cholesterol

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

  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

  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

  Baseline

• Triglycerides

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

  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

  Baseline

• Zinc

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

  Baseline

• Iron

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

  Baseline

• Plasma Metabolome

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

  Baseline

• Intestinal Barrier Function

  Determination of the intestinal barrier function in a patient subgroup in comparison to control patients (using proximal small intestinal biopsies, qRT-PCR (Real Time Polymerase Chain Reaction) of different intestinal barrier markers)

  Baseline

• Expression of Intestinal Ion Transporters

  Determination of the expression of intestinal ion transporters in a patient subgroup in comparison to control patients (using proximal small intestinal biopsies, qRT-PCR (Real Time Polymerase Chain Reaction) of different intestinal transport markers)

  Baseline

Secondary Outcomes (3)

• Malnutrition-Sarcopenia Score

  Baseline

• Validity of the Study of Health in Pomerania Food Frequency Questionnaire

  Baseline

• Factor Analysis of Phenotypes of Sarcopenia and Malnutrition

  Baseline

Study Arms (5)

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

No intervention - cross-sectional observational only OTHER

No intervention - cross-sectional observational only

Chronic Pancreatitis; Control Patients; Healthy Controls; Liver Cirrhosis; Short Bowel Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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)
• if, contrary to expectations, malnutrition is diagnosed in spite of an inconspicuous NRS-2002 within the framework of the study
• as well as in the case of relevant, conspicuous esophago-gastro-duodenoscopy findings
• Liver Cirrhosis:
• steatohepatitis according to clinical or laboratory parameters
• acute alcoholic hepatitis according to clinical and imaging parameters (sonography, CT, MRI)
• existing transjugular intrahepatic portosystemic shunt (TIPS)
• known hepatocellular carcinoma (HCC)
• state after liver transplantation
• Chronic Pancreatitis:
• acute pancreatitis

Sponsors & Collaborators

• University Medicine Greifswald: lead
• University Medical Center Rostock: collaborator
• University of Applied Sciences Neubrandenburg: collaborator
• Leibniz Institute for Farm Animal Biology (FBN): collaborator

Study Sites (3)

University Medicine Greifswald

Greifswald, 17475, Germany

Location

University of Applied Sciences Neubrandenburg

Neubrandenburg, 17033, Germany

Location

Univeristy Medicine Rostock

Rostock, 18057, Germany

Location

Related Publications (1)

• 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.

  PMID: 35719155 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood Plasma, Faeces, Urine, Proximal Small Intestinal Biopsies

MeSH Terms

Conditions

Pancreatitis, Chronic; Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Postoperative Complications

Study Officials

• Prof. Dr. med. Lamprecht

  University Medicine Rostock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 17, 2020
• Study Start: October 2, 2018
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-11

Locations

DE (3)