Assessment of Nutritional Status of Patients With Liver Cirrhosis
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|ClinicalTrials.gov Identifier: NCT03242798|
Recruitment Status : Active, not recruiting
First Posted : August 8, 2017
Last Update Posted : March 4, 2019
|Condition or disease|
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 :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Assessment of Nutritional Status of Patients With Liver Cirrhosis|
|Actual Study Start Date :||March 3, 2016|
|Actual Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||March 2020|
- 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.
- Survival. [ Time Frame: One year after baseline measurements ]Assessment of survival one year after baseline measurements and association with the malnutrition phenotypes at baseline.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242798
|Kallithea, Attiki, Greece, 17671|
|Study Director:||Meropi D. Kontogianni, PhD||Harokopio University|