Malnutrition in Chronic Pancreatitis, Trans-sectoral Study

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04476056
• Other study ID #: BB 069/19
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2020
• Source: University Medicine Greifswald
• Contact: Prof. Dr. med. Markus M. Lerch
• Phone: +493834867230
• Email: markus.lerch[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Malnutrition
• Pancreatitis
• Pancreatitis, Chronic
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	University of Applied Sciences Neubrandenburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Dropout Rate	Dropout Rate	28 days, 3 months, 6 months
Secondary	Compliance to Oral Nutritional Supplements	Compliance is assessed by a standardized telephone interview comparing recommended and current intake	28 days, 3 months, 6 months
Secondary	Compliance to Dietary Counselling	Compliance is assessed via standardized telephone interview comparing scheduled and cancelled sessions	28 days, 3 months, 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Reduced Gait Speed	Changes in prevalence of reduced gait speed (< 0,8 m/s)	28 days, 3 months, 6 months
Secondary	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
Secondary	Body Weight	Changes in body weight measured in kilograms	28 days, 3 months, 6 months
Secondary	Height	Changes height measured in centimeters	28 days, 3 months, 6 months
Secondary	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
Secondary	Waist Circumference	Changes in waist circumference measured in centimeters	28 days, 3 months, 6 months
Secondary	Hip Circumference	Changes in hip circumference measured in centimeters	28 days, 3 months, 6 months
Secondary	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
Secondary	Triceps Skinfold Thickness	Changes in triceps skinfold thickness measured in millimeters	28 days, 3 months, 6 months
Secondary	Upper Arm Circumference	Changes in upper arm circumference measured in centimeters	28 days, 3 months, 6 months
Secondary	Fat Free Mass	Changes in fat free mass measured by Bioelectrical Impedance Analysis (BIA)	28 days, 3 months, 6 months
Secondary	Skeletal Muscle Mass	Changes in skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)	28 days, 3 months, 6 months
Secondary	Fat Mass	Changes in fat mass measured by Bioelectrical Impedance Analysis (BIA)	28 days, 3 months, 6 months
Secondary	Total Body Water	Changes in total body water measured by Bioelectrical Impedance Analysis (BIA)	28 days, 3 months, 6 months
Secondary	Extracellular Water	Changes in extracellular water measured by Bioelectrical Impedance Analysis (BIA)	28 days, 3 months, 6 months
Secondary	Phase Angle	Changes in phase angle measured by Bioelectrical Impedance Analysis (BIA)	28 days, 3 months, 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hemoglobin	Changes in hemoglobin level	28 days, 3 months, 6 months
Secondary	Hematocrit	Changes in hematocrit level	28 days, 3 months, 6 months
Secondary	Mean Corpuscular Volume	Changes in mean corpuscular volume	28 days, 3 months, 6 months
Secondary	Mean Corpuscular Hemoglobin Concentration	Changes in mean corpuscular hemoglobin concentration	28 days, 3 months, 6 months
Secondary	Reticulocyte Count	Changes in reticulocyte count	28 days, 3 months, 6 months
Secondary	Sodium	Changes in plasma concentration of sodium	28 days, 3 months, 6 months
Secondary	Potassium	Changes in plasma concentration of potassium	28 days, 3 months, 6 months
Secondary	Calcium	Changes in plasma concentration of calcium	28 days, 3 months, 6 months
Secondary	Magnesium	Changes in plasma concentration of magnesium	28 days, 3 months, 6 months
Secondary	Phosphate	Changes in plasma concentration of phosphate	28 days, 3 months, 6 months
Secondary	Aspartate Transaminase	Changes in plasma concentration of aspartate transferase	28 days, 3 months, 6 months
Secondary	Alanine Aminotransferase	Changes in plasma concentration of alanine aminotransferase	28 days, 3 months, 6 months
Secondary	Gamma-glutamyl Transferase	Changes in plasma concentration of gamma-glutamyl transferase	28 days, 3 months, 6 months
Secondary	Alkaline Phosphatase	Changes in plasma concentration of alkaline phosphatase	28 days, 3 months, 6 months
Secondary	Bilirubin	Changes in plasma concentration of bilirubin	28 days, 3 months, 6 months
Secondary	C-reactive Protein	Changes in plasma concentration of C-reactive protein	28 days, 3 months, 6 months
Secondary	Interleukin-1 Beta	Changes in serum concentration of interleukin-1 beta	28 days, 3 months, 6 months
Secondary	Interleukin-6	Changes in plasma concentration of interleukin-6	28 days, 3 months, 6 months
Secondary	Tumor Necrosis Factor Alpha	Changes in serum concentration of tumor necrosis factor alpha	28 days, 3 months, 6 months
Secondary	Albumin	Changes in plasma concentration of albumin	28 days, 3 months, 6 months
Secondary	Creatinine	Changes in plasma concentration of creatinine	28 days, 3 months, 6 months
Secondary	Urea	Changes in plasma concentration of urea	28 days, 3 months, 6 months
Secondary	Uric Acid	Changes in plasma concentration of uric acid	28 days, 3 months, 6 months
Secondary	Glucose	Changes in plasma concentration of glucose	28 days, 3 months, 6 months
Secondary	Glycated hemoglobin	Changes in plasma concentration of glycated hemoglobin	28 days, 3 months, 6 months
Secondary	Insulin	Changes in serum concentration of insulin	28 days, 3 months, 6 months
Secondary	Total Cholesterol	Changes in plasma concentration of total cholesterol	28 days, 3 months, 6 months
Secondary	High-density Lipoprotein Cholesterol	Changes in plasma concentration of high-density lipoprotein cholesterol	28 days, 3 months, 6 months
Secondary	Low-density Lipoprotein Cholesterol	Changes in plasma concentration of high-density lipoprotein cholesterol	28 days, 3 months, 6 months
Secondary	Triglycerides	Changes in plasma concentration of triglycerides	28 days, 3 months, 6 months
Secondary	Non-essential Fatty Acids	Changes in plasma concentration of non-essential fatty acids	28 days, 3 months, 6 months
Secondary	Zinc	Changes in serum concentration of zinc	28 days, 3 months, 6 months
Secondary	Iron	Changes in plasma concentration of iron	28 days, 3 months, 6 months
Secondary	Hand Grip Strength	Changes in maximal hand grip strength	28 days, 3 months, 6 months
Secondary	Gait Speed	Changes in gait speed	28 days, 3 months, 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Intestinal Microbiome	Changes in the intestinal microbiome	28 days, 3 months, 6 months
Secondary	Plasma Metabolome	Changes in the plasma metabolome	28 days, 3 months, 6 months
Secondary	Plasma Transcriptome	Changes in the plasma transcriptome	28 days, 3 months, 6 months