Clinical Trials Directory

Trials / Completed

CompletedNCT04474743

Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study

Multi-center, Controlled Cross-sectional Analysis of the Phenotype of Malnutrition in Patients With Liver Cirrhosis, Chronic Pancreatitis and Short Bowel Syndrome (as Part of the Joint Project "Enteral Nutrition in Malnutrition Due to Diseases of the Gastrointestinal Tract: From Basic Understanding to an Innovative Treatment Concept" (EnErGie))

Status
Completed
Phase
Study type
Observational
Enrollment
345 (actual)
Sponsor
University Medicine Greifswald · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

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

Interventions

TypeNameDescription
OTHERNo intervention - cross-sectional observational onlyNo intervention - cross-sectional observational only

Timeline

Start date
2018-10-02
Primary completion
2021-09-13
Completion
2021-09-13
First posted
2020-07-17
Last updated
2021-11-02

Locations

3 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT04474743. Inclusion in this directory is not an endorsement.