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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04476056
Other study ID # BB 069/19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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