- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03242798
Assessment of Nutritional Status of Patients With Liver Cirrhosis
Study Overview
Status
Conditions
Detailed Description
The study sample will comprise of 170 adults with biopsy proven cirrhosis. A detailed medical and nutritional assessment will be implemented at baseline. For patients that will receive an intervention aiming at the cause of cirrhosis (e.g. antivirus therapy for HCV or HBV) the baseline assessment will take place before the beginning of the therapy and will be repeated three months after the completion of the medical intervention to explore the impact of the intervention on nutritional status. Data regarding the survival of all the patients will be collected one year after the baseline assessment.
More specifically regarding the detailed assessment, firstly, hepatologists of the research team will complete a full medical record regarding the primary disease, cirrhosis' complications, comorbidities and medication. The severity of cirrhosis will be assessed using the Child-Pugh score. Furthermore, in the Laboratory of Clinical Nutrition & Dietetics at Harokopio University, patients will participate in the following procedures:
- Anthropometry: Weight, height, waist and mid-arm circumference, and triceps skinfold will be measured. Body mass index, mid-arm muscle circumference and area will be estimated using standard equations.
- Body composition analysis: Total body DXA (Lunar DPX-MD, Madison, WI, USA) will be performed.
- Muscle strength and performance status: Handgrip strength measurement based on certain protocol and the "Short Physical Performance Battery" tool will be implemented.
- Dietary intake evaluation: Three non-consecutive 24h recalls (two weekdays and one weekend day) will be recorded. Data will be analyzed to estimate energy, macro- and micronutrients intake (Nutritionist Pro software, 2.2 version). Food group intake and meal patterns will also be evaluated.
- Physical activity assessment: Patients' physical activity levels will be assessed using the "Harokopio Physical Activity Questionnaire".
For patients with available upper abdomen computed tomographies skeletal muscle index at L3 will be calculated with the software SliceOmatic V5.0 software, Tomovision, Montreal, PQ. In addition, patients' nutritional risk or nutritional status will be assessed through several previously validated tools like the Subjective Global Assessment, the Royal Free Hospital Global assessment scheme and Liver Disease Undernutrition Screening Tool, the efficacy of which will be tested in the present study. Patients will be also categorized according to ESPEN's recent malnutrition diagnostic criteria.
The full assessment will be repeated only for patients who will receive an intervention aiming at the cause of cirrhosis (e.g. antivirus therapy for HCV or HBV) three months after the completion of the medical intervention.
One year after the baseline assessment of the study samples, data will be collected regarding survival, development of complications and decompensated cirrhosis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Attiki
-
Kallithea, Attiki, Greece, 17671
- Harokopio University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Adults with biopsy proven cirrhosis.
Exclusion Criteria:
Patients with hepatocellular carcinoma, in hepatic coma, with acquired immunodeficiency syndrome, with renal or pancreatic insufficiency, receiving enteral nutrition or being pregnant, will be excluded.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of malnutrition phenotypes.
Time Frame: Baseline
|
Prevalence of different malnutrition phenotypes (e.g.
undernutrition, sarcopenia, sarcopenic obesity), in cirrhotic patients of different disease stages, by implementing a thorough nutritional assessment.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival.
Time Frame: One year after baseline measurements
|
Assessment of survival one year after baseline measurements and association with the malnutrition phenotypes at baseline.
|
One year after baseline measurements
|
Validity test of available tools.
Time Frame: Baseline
|
Test the sensitivity, specificity, positive and negative prognostic values of already available tools for nutritional screening or assessment against a combined index as the reference tool.
If no tool is estimated as valid, a new combination of nutritional, biochemical and/or clinical parameters will be synthesized and its validity as a new screening or assessment tool will be assessed for the detection of cirrhotic patients at risk of malnutrition or already malnourished.
|
Baseline
|
Nutritional status after medical treatment according to the etiology of cirrhosis.
Time Frame: 6 months after baseline measurements
|
Changes in the nutritional status after medical treatment according to the etiology of cirrhosis, namely antivirus therapy for HCV or HBV cirrhosis, abstinence from alcohol in the alcoholic cirrhosis, immunosuppressive therapy in autoimmune cirrhosis.
|
6 months after baseline measurements
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Meropi D. Kontogianni, PhD, Harokopio University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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