Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT04476056
Status:
UNKNOWN
Last Update Posted:
2020-07-17
First Post:
2020-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Malnutrition in Chronic Pancreatitis, Trans-sectoral Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Feasibility Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) Criteria', 'timeFrame': '6 months', 'description': 'Changes from baseline prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria after 6 months'}], 'secondaryOutcomes': [{'measure': 'Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) criteria', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria'}, {'measure': 'Dropout Rate', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Dropout Rate'}, {'measure': 'Compliance to Oral Nutritional Supplements', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Compliance is assessed by a standardized telephone interview comparing recommended and current intake'}, {'measure': 'Compliance to Dietary Counselling', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Compliance is assessed via standardized telephone interview comparing scheduled and cancelled sessions'}, {'measure': 'Malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Prevalence of malnutrition according to the Global Leadership Initiative on Malnutrition criteria'}, {'measure': 'Sarcopenia according to EWGSOP 2 (European Working Group on Sarcopenia in Older People 2) criteria', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Prevalence of sarcopenia according to the European Working Group on Sarcopenia in Older People 2 criteria'}, {'measure': 'Reduced Body Mass Index', 'timeFrame': '28 days, 3 months, 6 months', 'description': '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)'}, {'measure': 'Reduced Fat Free Mass Index', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in prevalence of reduced fat free mass index (≤ 15 kg/m² if female, ≤ 17 kg/m² if male)'}, {'measure': 'Reduced Skeletal Muscle Mass Index', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in prevalence of reduced skeletal muscle mass index (≤ 6,42 kg/m² if female, ≤ 8,87 kg/m² if male)'}, {'measure': 'Reduced Gait Speed', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in prevalence of reduced gait speed (\\< 0,8 m/s)'}, {'measure': 'Reduced Muscle Strength', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in prevalence of reduced muscle strength (\\< 19,3 kg if female, \\< 30,3 kg if male)'}, {'measure': 'Body Weight', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in body weight measured in kilograms'}, {'measure': 'Height', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes height measured in centimeters'}, {'measure': 'Body Mass Index', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in body mass index measured in kg/m\\^2 (calculated from the values obtained for body weight and height)'}, {'measure': 'Waist Circumference', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in waist circumference measured in centimeters'}, {'measure': 'Hip Circumference', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in hip circumference measured in centimeters'}, {'measure': 'Waist-to-Hip Ratio', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)'}, {'measure': 'Triceps Skinfold Thickness', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in triceps skinfold thickness measured in millimeters'}, {'measure': 'Upper Arm Circumference', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in upper arm circumference measured in centimeters'}, {'measure': 'Fat Free Mass', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in fat free mass measured by Bioelectrical Impedance Analysis (BIA)'}, {'measure': 'Skeletal Muscle Mass', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)'}, {'measure': 'Fat Mass', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in fat mass measured by Bioelectrical Impedance Analysis (BIA)'}, {'measure': 'Total Body Water', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in total body water measured by Bioelectrical Impedance Analysis (BIA)'}, {'measure': 'Extracellular Water', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in extracellular water measured by Bioelectrical Impedance Analysis (BIA)'}, {'measure': 'Phase Angle', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in phase angle measured by Bioelectrical Impedance Analysis (BIA)'}, {'measure': 'Energy Intake', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in energy intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)'}, {'measure': 'Protein Intake', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in protein intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)'}, {'measure': 'Carbohydrate Intake', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in carbohydrate intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)'}, {'measure': 'Fat Intake', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in fat intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)'}, {'measure': 'Dietary Fiber Intake', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in dietary fiber intake assessed by the German Health Interview and Examination Survey for Adults Food Frequency Questionnaire (DEGS-FFQ)'}, {'measure': 'Physical Activity', 'timeFrame': '28 days, 3 months, 6 months', 'description': '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'}, {'measure': 'Hemoglobin', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in hemoglobin level'}, {'measure': 'Hematocrit', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in hematocrit level'}, {'measure': 'Mean Corpuscular Volume', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in mean corpuscular volume'}, {'measure': 'Mean Corpuscular Hemoglobin Concentration', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in mean corpuscular hemoglobin concentration'}, {'measure': 'Reticulocyte Count', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in reticulocyte count'}, {'measure': 'Sodium', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of sodium'}, {'measure': 'Potassium', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of potassium'}, {'measure': 'Calcium', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of calcium'}, {'measure': 'Magnesium', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of magnesium'}, {'measure': 'Phosphate', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of phosphate'}, {'measure': 'Aspartate Transaminase', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of aspartate transferase'}, {'measure': 'Alanine Aminotransferase', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of alanine aminotransferase'}, {'measure': 'Gamma-glutamyl Transferase', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of gamma-glutamyl transferase'}, {'measure': 'Alkaline Phosphatase', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of alkaline phosphatase'}, {'measure': 'Bilirubin', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of bilirubin'}, {'measure': 'C-reactive Protein', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of C-reactive protein'}, {'measure': 'Interleukin-1 Beta', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in serum concentration of interleukin-1 beta'}, {'measure': 'Interleukin-6', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of interleukin-6'}, {'measure': 'Tumor Necrosis Factor Alpha', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in serum concentration of tumor necrosis factor alpha'}, {'measure': 'Albumin', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of albumin'}, {'measure': 'Creatinine', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of creatinine'}, {'measure': 'Urea', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of urea'}, {'measure': 'Uric Acid', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of uric acid'}, {'measure': 'Glucose', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of glucose'}, {'measure': 'Glycated hemoglobin', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of glycated hemoglobin'}, {'measure': 'Insulin', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in serum concentration of insulin'}, {'measure': 'Total Cholesterol', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of total cholesterol'}, {'measure': 'High-density Lipoprotein Cholesterol', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of high-density lipoprotein cholesterol'}, {'measure': 'Low-density Lipoprotein Cholesterol', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of high-density lipoprotein cholesterol'}, {'measure': 'Triglycerides', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of triglycerides'}, {'measure': 'Non-essential Fatty Acids', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of non-essential fatty acids'}, {'measure': 'Zinc', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in serum concentration of zinc'}, {'measure': 'Iron', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in plasma concentration of iron'}, {'measure': 'Hand Grip Strength', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in maximal hand grip strength'}, {'measure': 'Gait Speed', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in gait speed'}, {'measure': 'Anxiety and Depression', 'timeFrame': '28 days, 3 months, 6 months', 'description': '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.'}, {'measure': 'Fatigue', 'timeFrame': '28 days, 3 months, 6 months', 'description': '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.'}, {'measure': 'Loneliness', 'timeFrame': '28 days, 3 months, 6 months', 'description': '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.'}, {'measure': 'Intestinal Microbiome', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in the intestinal microbiome'}, {'measure': 'Plasma Metabolome', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in the plasma metabolome'}, {'measure': 'Plasma Transcriptome', 'timeFrame': '28 days, 3 months, 6 months', 'description': 'Changes in the plasma transcriptome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pancreatitis', 'Malnutrition', 'Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '39440042', 'type': 'DERIVED', 'citation': 'Wiese ML, Frost F, Meyer F, Muller J, Valentini L, Rischmuller K, Lamprecht G, Steveling A, Lerch MM, Aghdassi AA. An intensified trans-sectoral nutritional intervention in malnourished patients with chronic pancreatitis improves diseases prognosis and identifies potential biomarkers of nutritional status. Front Med (Lausanne). 2024 Oct 8;11:1446699. doi: 10.3389/fmed.2024.1446699. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic pancreatitis verified by histology or imaging modality (endoscopic ultrasound, computed tomography, magnetic resonance imaging, magnetic resonance cholangiopancreatography)\n* Diagnosis of malnutrition\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Implanted defibrillator or pacemaker\n* History of pancreatic Cancer\n* Any other malignant tumor disease within the last 3 years\n* Concomitant liver cirrhosis'}, 'identificationModule': {'nctId': 'NCT04476056', 'briefTitle': 'Malnutrition in Chronic Pancreatitis, Trans-sectoral Study', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Analysis of Trans-sectoral Nutritional Care of Malnourished Patients With Chronic Pancreatitis Over 6 Months', 'orgStudyIdInfo': {'id': 'BB 069/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chronic Pancreatitis + Malnutrition', 'description': 'Malnourished patients with chronic pancreatitis will receive intensified nutritional therapy for 6 months.', 'interventionNames': ['Other: Intensified Nutritional Therapy']}], 'interventions': [{'name': 'Intensified Nutritional Therapy', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Chronic Pancreatitis + Malnutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17475', 'city': 'Greifswald', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Prof. Dr. med. Markus M. Lerch', 'role': 'CONTACT', 'email': 'markus.lerch@med.uni-greifswald.de', 'phone': '+493834867230'}, {'name': 'Ali A Aghdassi, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Simone Gärtner, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mats Wiese, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Medicine Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'centralContacts': [{'name': 'Prof. Dr. med. Markus M. Lerch', 'role': 'CONTACT', 'email': 'markus.lerch@med.uni-greifswald.de', 'phone': '+493834867230'}], 'overallOfficials': [{'name': 'Prof. Dr. med. Markus M. Lerch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medicine Greifswald'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Applied Sciences Neubrandenburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}