Malnutrition in Chronic Pancreatitis, Trans-sectoral Study

July 13, 2020 updated by: University Medicine Greifswald

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Greifswald, Germany, 17475
        • Recruiting
        • University Medicine Greifswald
        • Contact:
        • Sub-Investigator:
          • Ali A Aghdassi, Dr.
        • Sub-Investigator:
          • Simone Gärtner, Dr.
        • Sub-Investigator:
          • Mats Wiese, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) Criteria
Time Frame: 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) criteria
Time Frame: 28 days, 3 months, 6 months
Prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria
28 days, 3 months, 6 months
Dropout Rate
Time Frame: 28 days, 3 months, 6 months
Dropout Rate
28 days, 3 months, 6 months
Compliance to Oral Nutritional Supplements
Time Frame: 28 days, 3 months, 6 months
Compliance is assessed by a standardized telephone interview comparing recommended and current intake
28 days, 3 months, 6 months
Compliance to Dietary Counselling
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
Changes in prevalence of reduced gait speed (< 0,8 m/s)
28 days, 3 months, 6 months
Reduced Muscle Strength
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
Changes in body weight measured in kilograms
28 days, 3 months, 6 months
Height
Time Frame: 28 days, 3 months, 6 months
Changes height measured in centimeters
28 days, 3 months, 6 months
Body Mass Index
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
Changes in waist circumference measured in centimeters
28 days, 3 months, 6 months
Hip Circumference
Time Frame: 28 days, 3 months, 6 months
Changes in hip circumference measured in centimeters
28 days, 3 months, 6 months
Waist-to-Hip Ratio
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
Changes in triceps skinfold thickness measured in millimeters
28 days, 3 months, 6 months
Upper Arm Circumference
Time Frame: 28 days, 3 months, 6 months
Changes in upper arm circumference measured in centimeters
28 days, 3 months, 6 months
Fat Free Mass
Time Frame: 28 days, 3 months, 6 months
Changes in fat free mass measured by Bioelectrical Impedance Analysis (BIA)
28 days, 3 months, 6 months
Skeletal Muscle Mass
Time Frame: 28 days, 3 months, 6 months
Changes in skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)
28 days, 3 months, 6 months
Fat Mass
Time Frame: 28 days, 3 months, 6 months
Changes in fat mass measured by Bioelectrical Impedance Analysis (BIA)
28 days, 3 months, 6 months
Total Body Water
Time Frame: 28 days, 3 months, 6 months
Changes in total body water measured by Bioelectrical Impedance Analysis (BIA)
28 days, 3 months, 6 months
Extracellular Water
Time Frame: 28 days, 3 months, 6 months
Changes in extracellular water measured by Bioelectrical Impedance Analysis (BIA)
28 days, 3 months, 6 months
Phase Angle
Time Frame: 28 days, 3 months, 6 months
Changes in phase angle measured by Bioelectrical Impedance Analysis (BIA)
28 days, 3 months, 6 months
Energy Intake
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
Changes in hemoglobin level
28 days, 3 months, 6 months
Hematocrit
Time Frame: 28 days, 3 months, 6 months
Changes in hematocrit level
28 days, 3 months, 6 months
Mean Corpuscular Volume
Time Frame: 28 days, 3 months, 6 months
Changes in mean corpuscular volume
28 days, 3 months, 6 months
Mean Corpuscular Hemoglobin Concentration
Time Frame: 28 days, 3 months, 6 months
Changes in mean corpuscular hemoglobin concentration
28 days, 3 months, 6 months
Reticulocyte Count
Time Frame: 28 days, 3 months, 6 months
Changes in reticulocyte count
28 days, 3 months, 6 months
Sodium
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of sodium
28 days, 3 months, 6 months
Potassium
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of potassium
28 days, 3 months, 6 months
Calcium
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of calcium
28 days, 3 months, 6 months
Magnesium
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of magnesium
28 days, 3 months, 6 months
Phosphate
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of phosphate
28 days, 3 months, 6 months
Aspartate Transaminase
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of aspartate transferase
28 days, 3 months, 6 months
Alanine Aminotransferase
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of alanine aminotransferase
28 days, 3 months, 6 months
Gamma-glutamyl Transferase
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of gamma-glutamyl transferase
28 days, 3 months, 6 months
Alkaline Phosphatase
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of alkaline phosphatase
28 days, 3 months, 6 months
Bilirubin
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of bilirubin
28 days, 3 months, 6 months
C-reactive Protein
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of C-reactive protein
28 days, 3 months, 6 months
Interleukin-1 Beta
Time Frame: 28 days, 3 months, 6 months
Changes in serum concentration of interleukin-1 beta
28 days, 3 months, 6 months
Interleukin-6
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of interleukin-6
28 days, 3 months, 6 months
Tumor Necrosis Factor Alpha
Time Frame: 28 days, 3 months, 6 months
Changes in serum concentration of tumor necrosis factor alpha
28 days, 3 months, 6 months
Albumin
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of albumin
28 days, 3 months, 6 months
Creatinine
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of creatinine
28 days, 3 months, 6 months
Urea
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of urea
28 days, 3 months, 6 months
Uric Acid
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of uric acid
28 days, 3 months, 6 months
Glucose
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of glucose
28 days, 3 months, 6 months
Glycated hemoglobin
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of glycated hemoglobin
28 days, 3 months, 6 months
Insulin
Time Frame: 28 days, 3 months, 6 months
Changes in serum concentration of insulin
28 days, 3 months, 6 months
Total Cholesterol
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of total cholesterol
28 days, 3 months, 6 months
High-density Lipoprotein Cholesterol
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of high-density lipoprotein cholesterol
28 days, 3 months, 6 months
Low-density Lipoprotein Cholesterol
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of high-density lipoprotein cholesterol
28 days, 3 months, 6 months
Triglycerides
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of triglycerides
28 days, 3 months, 6 months
Non-essential Fatty Acids
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of non-essential fatty acids
28 days, 3 months, 6 months
Zinc
Time Frame: 28 days, 3 months, 6 months
Changes in serum concentration of zinc
28 days, 3 months, 6 months
Iron
Time Frame: 28 days, 3 months, 6 months
Changes in plasma concentration of iron
28 days, 3 months, 6 months
Hand Grip Strength
Time Frame: 28 days, 3 months, 6 months
Changes in maximal hand grip strength
28 days, 3 months, 6 months
Gait Speed
Time Frame: 28 days, 3 months, 6 months
Changes in gait speed
28 days, 3 months, 6 months
Anxiety and Depression
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
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
Time Frame: 28 days, 3 months, 6 months
Changes in the intestinal microbiome
28 days, 3 months, 6 months
Plasma Metabolome
Time Frame: 28 days, 3 months, 6 months
Changes in the plasma metabolome
28 days, 3 months, 6 months
Plasma Transcriptome
Time Frame: 28 days, 3 months, 6 months
Changes in the plasma transcriptome
28 days, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medicine Greifswald

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Applied Sciences Neubrandenburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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