Clinical trial NCT04476056: Malnutrition in Chronic Pancreatitis, Trans-sectoral Study
Official title: Analysis of Trans-sectoral Nutritional Care of Malnourished Patients With Chronic Pancreatitis Over 6 Months
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pancreatitis
Malnutrition
Sarcopenia
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences Neubrandenburg
First posted: 2020-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility Study
Primary purpose: TREATMENT

Brief summary: Malnutrition and loss of muscle mass are common in patients with chronic pancreatitis. However, there is only limited data on nutritional treatment. In this study, malnourished patients with chronic pancreatitis will receive an intensified nutritional therapy to improve nutritional status. The aim of the study is that malnutrition in patients with chronic pancreatitis can be successfully treated.

Detailed description: Malnutrition and sarcopenia are common complications in chronic pancreatitis leading to increased morbidity and mortality. Therefore nutritional therapy can be considered imperative. However, there is limited evidence on the treatment of malnutrition in patients with chronic pancreatitis. This study aims to investigate the effect of an intensified nutritional therapy on nutritional status in malnourished patients with chronic pancreatitis. By testing feasibility of this intensified therapy valuable recommendations for future treatment of malnutrition in patients with chronic pancreatitis can be derived.

Eligibility criteria: Inclusion Criteria:

* Chronic pancreatitis verified by histology or imaging modality (endoscopic ultrasound, computed tomography, magnetic resonance imaging, magnetic resonance cholangiopancreatography)
* Diagnosis of malnutrition

Exclusion Criteria:

* Pregnant or breast feeding
* Implanted defibrillator or pacemaker
* History of pancreatic Cancer
* Any other malignant tumor disease within the last 3 years
* Concomitant liver cirrhosis

Primary outcomes:
measure: Changes in Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) Criteria
timeFrame: 6 months
Secondary outcomes:
measure: Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) criteria
timeFrame: 28 days, 3 months, 6 months
measure: Dropout Rate
timeFrame: 28 days, 3 months, 6 months
measure: Compliance to Oral Nutritional Supplements
timeFrame: 28 days, 3 months, 6 months
measure: Compliance to Dietary Counselling
timeFrame: 28 days, 3 months, 6 months
measure: Malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria
timeFrame: 28 days, 3 months, 6 months
measure: Sarcopenia according to EWGSOP 2 (European Working Group on Sarcopenia in Older People 2) criteria
timeFrame: 28 days, 3 months, 6 months
measure: Reduced Body Mass Index
timeFrame: 28 days, 3 months, 6 months
measure: Reduced Fat Free Mass Index
timeFrame: 28 days, 3 months, 6 months
measure: Reduced Skeletal Muscle Mass Index
timeFrame: 28 days, 3 months, 6 months
measure: Reduced Gait Speed
timeFrame: 28 days, 3 months, 6 months
measure: Reduced Muscle Strength
timeFrame: 28 days, 3 months, 6 months
measure: Body Weight
timeFrame: 28 days, 3 months, 6 months
measure: Height
timeFrame: 28 days, 3 months, 6 months
measure: Body Mass Index
timeFrame: 28 days, 3 months, 6 months
measure: Waist Circumference
timeFrame: 28 days, 3 months, 6 months
measure: Hip Circumference
timeFrame: 28 days, 3 months, 6 months
measure: Waist-to-Hip Ratio
timeFrame: 28 days, 3 months, 6 months
measure: Triceps Skinfold Thickness
timeFrame: 28 days, 3 months, 6 months
measure: Upper Arm Circumference
timeFrame: 28 days, 3 months, 6 months
measure: Fat Free Mass
timeFrame: 28 days, 3 months, 6 months
measure: Skeletal Muscle Mass
timeFrame: 28 days, 3 months, 6 months
measure: Fat Mass
timeFrame: 28 days, 3 months, 6 months
measure: Total Body Water
timeFrame: 28 days, 3 months, 6 months
measure: Extracellular Water
timeFrame: 28 days, 3 months, 6 months
measure: Phase Angle
timeFrame: 28 days, 3 months, 6 months
measure: Energy Intake
timeFrame: 28 days, 3 months, 6 months
measure: Protein Intake
timeFrame: 28 days, 3 months, 6 months
measure: Carbohydrate Intake
timeFrame: 28 days, 3 months, 6 months
measure: Fat Intake
timeFrame: 28 days, 3 months, 6 months
measure: Dietary Fiber Intake
timeFrame: 28 days, 3 months, 6 months
measure: Physical Activity
timeFrame: 28 days, 3 months, 6 months
measure: Hemoglobin
timeFrame: 28 days, 3 months, 6 months
measure: Hematocrit
timeFrame: 28 days, 3 months, 6 months
measure: Mean Corpuscular Volume
timeFrame: 28 days, 3 months, 6 months
measure: Mean Corpuscular Hemoglobin Concentration
timeFrame: 28 days, 3 months, 6 months
measure: Reticulocyte Count
timeFrame: 28 days, 3 months, 6 months
measure: Sodium
timeFrame: 28 days, 3 months, 6 months
measure: Potassium
timeFrame: 28 days, 3 months, 6 months
measure: Calcium
timeFrame: 28 days, 3 months, 6 months
measure: Magnesium
timeFrame: 28 days, 3 months, 6 months
measure: Phosphate
timeFrame: 28 days, 3 months, 6 months
measure: Aspartate Transaminase
timeFrame: 28 days, 3 months, 6 months
measure: Alanine Aminotransferase
timeFrame: 28 days, 3 months, 6 months
measure: Gamma-glutamyl Transferase
timeFrame: 28 days, 3 months, 6 months
measure: Alkaline Phosphatase
timeFrame: 28 days, 3 months, 6 months
measure: Bilirubin
timeFrame: 28 days, 3 months, 6 months
measure: C-reactive Protein
timeFrame: 28 days, 3 months, 6 months
measure: Interleukin-1 Beta
timeFrame: 28 days, 3 months, 6 months
measure: Interleukin-6
timeFrame: 28 days, 3 months, 6 months
measure: Tumor Necrosis Factor Alpha
timeFrame: 28 days, 3 months, 6 months
measure: Albumin
timeFrame: 28 days, 3 months, 6 months
measure: Creatinine
timeFrame: 28 days, 3 months, 6 months
measure: Urea
timeFrame: 28 days, 3 months, 6 months
measure: Uric Acid
timeFrame: 28 days, 3 months, 6 months
measure: Glucose
timeFrame: 28 days, 3 months, 6 months
measure: Glycated hemoglobin
timeFrame: 28 days, 3 months, 6 months
measure: Insulin
timeFrame: 28 days, 3 months, 6 months
measure: Total Cholesterol
timeFrame: 28 days, 3 months, 6 months
measure: High-density Lipoprotein Cholesterol
timeFrame: 28 days, 3 months, 6 months
measure: Low-density Lipoprotein Cholesterol
timeFrame: 28 days, 3 months, 6 months
measure: Triglycerides
timeFrame: 28 days, 3 months, 6 months
measure: Non-essential Fatty Acids
timeFrame: 28 days, 3 months, 6 months
measure: Zinc
timeFrame: 28 days, 3 months, 6 months
measure: Iron
timeFrame: 28 days, 3 months, 6 months
measure: Hand Grip Strength
timeFrame: 28 days, 3 months, 6 months
measure: Gait Speed
timeFrame: 28 days, 3 months, 6 months
measure: Anxiety and Depression
timeFrame: 28 days, 3 months, 6 months
measure: Fatigue
timeFrame: 28 days, 3 months, 6 months
measure: Loneliness
timeFrame: 28 days, 3 months, 6 months
measure: Intestinal Microbiome
timeFrame: 28 days, 3 months, 6 months
measure: Plasma Metabolome
timeFrame: 28 days, 3 months, 6 months
measure: Plasma Transcriptome
timeFrame: 28 days, 3 months, 6 months
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
Study officials:
affiliation: University Medicine Greifswald
name: Prof. Dr. med. Markus M. Lerch
role: PRINCIPAL_INVESTIGATOR
References: