Malnutrition in Chronic Pancreatitis, Trans-sectoral Study

Analysis of Trans-sectoral Nutritional Care of Malnourished Patients With Chronic Pancreatitis Over 6 Months

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.

Study Overview

• Status: Unknown
• Conditions: Malnutrition; Sarcopenia; Chronic Pancreatitis
• Intervention / Treatment: Other: Intensified Nutritional Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany, 17475
    • Recruiting
    • University Medicine Greifswald
    • Contact: Prof. Dr. med. Markus M. Lerch; Phone Number: +493834867230; Email: markus.lerch@med.uni-greifswald.de
    • Sub-Investigator: Ali A Aghdassi, Dr.
    • Sub-Investigator: Simone Gärtner, Dr.
    • Sub-Investigator: Mats Wiese, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Chronic Pancreatitis + Malnutrition; Malnourished patients with chronic pancreatitis will receive intensified nutritional therapy for 6 months.

Other: Intensified Nutritional Therapy; Intensified nutritional therapy will begin in the hospital setting and comprises intake of a commercial oral nutritional supplement (Fortimel Compact 2.4, Nutricia) twice per day as well as personalized dietary counselling. After discharge, supplementation will be continued for at least 28 days and if necessary throughout the entire study duration. Likewise, dietary counselling will be provided throughout the entire study period based on the patient's individual need. Dietary counselling is provided either face-to-face during the follow-up visits or remotely via telephone between visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) Criteria	Changes from baseline prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria after 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) criteria	Prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria	28 days, 3 months, 6 months
Dropout Rate	Dropout Rate	28 days, 3 months, 6 months
Compliance to Oral Nutritional Supplements	Compliance is assessed by a standardized telephone interview comparing recommended and current intake	28 days, 3 months, 6 months
Compliance to Dietary Counselling	Compliance is assessed via standardized telephone interview comparing scheduled and cancelled sessions	28 days, 3 months, 6 months
Malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria	Prevalence of malnutrition according to the Global Leadership Initiative on Malnutrition criteria	28 days, 3 months, 6 months
Sarcopenia according to EWGSOP 2 (European Working Group on Sarcopenia in Older People 2) criteria	Prevalence of sarcopenia according to the European Working Group on Sarcopenia in Older People 2 criteria	28 days, 3 months, 6 months
Reduced Body Mass Index	Changes in prevalence of reduced body mass index (< 18,5 kg/m², < 20 kg/m² if age < 70 yrs, < 22 kg/m² if age ≥ 70 yrs)	28 days, 3 months, 6 months
Reduced Fat Free Mass Index	Changes in prevalence of reduced fat free mass index (≤ 15 kg/m² if female, ≤ 17 kg/m² if male)	28 days, 3 months, 6 months
Reduced Skeletal Muscle Mass Index	Changes in prevalence of reduced skeletal muscle mass index (≤ 6,42 kg/m² if female, ≤ 8,87 kg/m² if male)	28 days, 3 months, 6 months
Reduced Gait Speed	Changes in prevalence of reduced gait speed (< 0,8 m/s)	28 days, 3 months, 6 months
Reduced Muscle Strength	Changes in prevalence of reduced muscle strength (< 19,3 kg if female, < 30,3 kg if male)	28 days, 3 months, 6 months
Body Weight	Changes in body weight measured in kilograms	28 days, 3 months, 6 months
Height	Changes height measured in centimeters	28 days, 3 months, 6 months
Body Mass Index	Changes in body mass index measured in kg/m^2 (calculated from the values obtained for body weight and height)	28 days, 3 months, 6 months
Waist Circumference	Changes in waist circumference measured in centimeters	28 days, 3 months, 6 months
Hip Circumference	Changes in hip circumference measured in centimeters	28 days, 3 months, 6 months
Waist-to-Hip Ratio	Changes in waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)	28 days, 3 months, 6 months
Triceps Skinfold Thickness	Changes in triceps skinfold thickness measured in millimeters	28 days, 3 months, 6 months
Upper Arm Circumference	Changes in upper arm circumference measured in centimeters	28 days, 3 months, 6 months
Fat Free Mass	Changes in fat free mass measured by Bioelectrical Impedance Analysis (BIA)	28 days, 3 months, 6 months
Skeletal Muscle Mass	Changes in skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)	28 days, 3 months, 6 months
Fat Mass	Changes in fat mass measured by Bioelectrical Impedance Analysis (BIA)	28 days, 3 months, 6 months
Total Body Water	Changes in total body water measured by Bioelectrical Impedance Analysis (BIA)	28 days, 3 months, 6 months
Extracellular Water	Changes in extracellular water measured by Bioelectrical Impedance Analysis (BIA)	28 days, 3 months, 6 months
Phase Angle	Changes in phase angle measured by Bioelectrical Impedance Analysis (BIA)	28 days, 3 months, 6 months
Energy Intake	Changes in energy intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)	28 days, 3 months, 6 months
Protein Intake	Changes in protein intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)	28 days, 3 months, 6 months
Carbohydrate Intake	Changes in carbohydrate intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)	28 days, 3 months, 6 months
Fat Intake	Changes in fat intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)	28 days, 3 months, 6 months
Dietary Fiber Intake	Changes in dietary fiber intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)	28 days, 3 months, 6 months
Physical Activity	Changes in metabolic equivalent of task per day and activity level are assessed by employment of the German version of the International Physical Activity Questionnaire (IPAQ) Short Form	28 days, 3 months, 6 months
Hemoglobin	Changes in hemoglobin level	28 days, 3 months, 6 months
Hematocrit	Changes in hematocrit level	28 days, 3 months, 6 months
Mean Corpuscular Volume	Changes in mean corpuscular volume	28 days, 3 months, 6 months
Mean Corpuscular Hemoglobin Concentration	Changes in mean corpuscular hemoglobin concentration	28 days, 3 months, 6 months
Reticulocyte Count	Changes in reticulocyte count	28 days, 3 months, 6 months
Sodium	Changes in plasma concentration of sodium	28 days, 3 months, 6 months
Potassium	Changes in plasma concentration of potassium	28 days, 3 months, 6 months
Calcium	Changes in plasma concentration of calcium	28 days, 3 months, 6 months
Magnesium	Changes in plasma concentration of magnesium	28 days, 3 months, 6 months
Phosphate	Changes in plasma concentration of phosphate	28 days, 3 months, 6 months
Aspartate Transaminase	Changes in plasma concentration of aspartate transferase	28 days, 3 months, 6 months
Alanine Aminotransferase	Changes in plasma concentration of alanine aminotransferase	28 days, 3 months, 6 months
Gamma-glutamyl Transferase	Changes in plasma concentration of gamma-glutamyl transferase	28 days, 3 months, 6 months
Alkaline Phosphatase	Changes in plasma concentration of alkaline phosphatase	28 days, 3 months, 6 months
Bilirubin	Changes in plasma concentration of bilirubin	28 days, 3 months, 6 months
C-reactive Protein	Changes in plasma concentration of C-reactive protein	28 days, 3 months, 6 months
Interleukin-1 Beta	Changes in serum concentration of interleukin-1 beta	28 days, 3 months, 6 months
Interleukin-6	Changes in plasma concentration of interleukin-6	28 days, 3 months, 6 months
Tumor Necrosis Factor Alpha	Changes in serum concentration of tumor necrosis factor alpha	28 days, 3 months, 6 months
Albumin	Changes in plasma concentration of albumin	28 days, 3 months, 6 months
Creatinine	Changes in plasma concentration of creatinine	28 days, 3 months, 6 months
Urea	Changes in plasma concentration of urea	28 days, 3 months, 6 months
Uric Acid	Changes in plasma concentration of uric acid	28 days, 3 months, 6 months
Glucose	Changes in plasma concentration of glucose	28 days, 3 months, 6 months
Glycated hemoglobin	Changes in plasma concentration of glycated hemoglobin	28 days, 3 months, 6 months
Insulin	Changes in serum concentration of insulin	28 days, 3 months, 6 months
Total Cholesterol	Changes in plasma concentration of total cholesterol	28 days, 3 months, 6 months
High-density Lipoprotein Cholesterol	Changes in plasma concentration of high-density lipoprotein cholesterol	28 days, 3 months, 6 months
Low-density Lipoprotein Cholesterol	Changes in plasma concentration of high-density lipoprotein cholesterol	28 days, 3 months, 6 months
Triglycerides	Changes in plasma concentration of triglycerides	28 days, 3 months, 6 months
Non-essential Fatty Acids	Changes in plasma concentration of non-essential fatty acids	28 days, 3 months, 6 months
Zinc	Changes in serum concentration of zinc	28 days, 3 months, 6 months
Iron	Changes in plasma concentration of iron	28 days, 3 months, 6 months
Hand Grip Strength	Changes in maximal hand grip strength	28 days, 3 months, 6 months
Gait Speed	Changes in gait speed	28 days, 3 months, 6 months
Anxiety and Depression	Changes in anxiety and depression assessed by the German version of the Hospital Anxiety and Depression Scale (HADS-D). For both the anxiety and the depression subscale scores range from 0-21, with higher values indicating a worse outcome.	28 days, 3 months, 6 months
Fatigue	Changes in fatigue assessed by the German version of the Fatigue Severity Scale (FSS). Scores range from 1-7, with higher values indicating a better outcome.	28 days, 3 months, 6 months
Loneliness	Changes in loneliness assessed by the German Version of the 6-item De Jong Gierveld Loneliness Scale. Scores range from 0-6, with higher values indicating worse outcome.	28 days, 3 months, 6 months
Intestinal Microbiome	Changes in the intestinal microbiome	28 days, 3 months, 6 months
Plasma Metabolome	Changes in the plasma metabolome	28 days, 3 months, 6 months
Plasma Transcriptome	Changes in the plasma transcriptome	28 days, 3 months, 6 months

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: University of Applied Sciences Neubrandenburg

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 28, 2019
• Primary Completion (ANTICIPATED): May 30, 2021
• Study Completion (ANTICIPATED): November 30, 2021

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (ACTUAL): July 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neurologic Manifestations; Nutrition Disorders; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pancreatic Diseases; Sarcopenia; Malnutrition; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: BB 069/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No