Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03242798 |
| Other study ID # |
105 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 3, 2016 |
| Est. completion date |
March 2020 |
Study information
| Verified date |
August 2022 |
| Source |
Harokopio University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Cirrhosis is the twelfth leading cause of death worldwide. Malnutrition is prevalent among
cirrhotic patients and is an important prognostic factor. Nutritional assessment is therefore
crucial for identifying patients at risk or with already established malnutrition and refer
them for nutritional intervention and support. In the current literature, nutritional
assessment of cirrhotic patients is performed using several tools and methods. However their
accuracy is widely affected by the underline disease and its complications. In addition, for
the majority of the parameters under study, no gold standard tools and methods have been
established so far. Studies on nutritional assessment in cirrhosis usually focus on one or
few aspects of nutritional status and not on a full nutritional assessment combining
information from medical, biochemical, nutritional, and body composition variables. Hence,
the present study aims at a thorough assessment of the nutritional status of 170 cirrhotic
patients using multiple widely available tools and methods, in order to assess their accuracy
and estimate the prevalence of multiple malnutrition phenotypes such as undernutrition,
sarcopenia, sarcopenic obesity and cachexia.
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.
