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| Name | Class |
|---|---|
| Fonds National de la Recherche Scientifique | OTHER |
| FRC- Fonds de la Recherche Clinique | UNKNOWN |
| SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation | UNKNOWN |
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Cachexia is common in patients with chronic kidney disease (CKD) and is associated with increased morbidity and mortality. Cachexia is a complex syndrome, in which inflammation and retention of uremic toxins are two main contributing factors. In this context, the role of the gut microbiome in CKD cachexia and the potential benefit of increasing the dialysis dose have been poorly explored. Here the investigators propose to study the links between cachexia and the gut microbiome, in association with inflammation and uremic toxins, in dialysis.
The specific objectives are the followings:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dialysis patients | Collection of clinical data and biological samples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of clinical data and biological sampling | Other | Multiple measures relevant to cachexia, such as body weight, body mass index (BMI), muscle mass (handgrip strength using a Jamar hand dynamometer, mid-upper arm muscle circumference), appetite (Functional Assessment of Anorexia/Cachexia Therapy [FAACT], Simplified Nutritional Appetite Questionnaire [SNAQ], Automated Self- Administered Dietary Assessment Tool [ASA24]) will be recorded at inclusion (T0), after 6 months (T6) and after one year of follow-up (T12). Body composition will be assessed by bioelectrical impedance analysis at T0, T6 and T12, and by CT-scan at T0 and T12. In parallel, gut microbiota composition on feces collection will be determined at the two time points (T0 and T12). Markers of systemic and intestinal inflammation will be assessed at T0 and T12. Serum levels of uremic toxins will be measured at T0 and T12. Human muscle biopsies will be performed at the time of a surgical intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Composition and function of the gut microbiota | Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition and function | Throughout the entire study, approximately during 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Level of inflammatory markers | Throughout the entire study, approximately during 5 years | |
| Level of uremic toxins | Throughout the entire study, approximately during 5 years | |
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Inclusion Criteria:
Exclusion Criteria:
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The patient population studied is adult kidney failure patients treated with hemodialysis (in-center, self-care dialysis in a satellite unit or at home) or with peritoneal dialysis for more than 3 months.
The principal investigator, who is a Nephrologist and works at the Nephrology Department, in Cliniques universitaires Saint-Luc, in contact with dialysis patients, will check patient eligibility, collect the consent from the subjects who agree to participate and allocate an ID number.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laure Bindels, PhD | Contact | +32(2)7647337 | laure.bindels@uclouvain.be | |
| Eric Goffin, MD | Contact | +32(2)7641855 | eric.goffin@saintluc.uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Inès Dufour, MD | Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Metabolomics profile |
| Throughout the entire study, approximately during 5 years |
| Dialysis dose | number of hours of dialysis per week | Throughout the entire study, approximately during 5 years |
| Dialysis modality | in-center hemodialysis vs self-care dialysis in a satellite unit vs home-hemodialysis vs peritoneal dialysis | Throughout the entire study, approximately during 5 years |
| Body composition | Bioelectrical impedance analysis (in kg) | Throughout the entire study, approximately during 5 years |
| Body composition | Noncontrast enhanced CT scan of the abdomen at the level of the third lumbar vertebra (L3) | Throughout the entire study, approximately during 5 years |
| Quality of life | FAACT (Functional Assessment of Anorexia-Cachexia Therapy) and FACIT (Functional Assessment of Chronic Illness Therapy - Fatigue Scale) questionnaires | Throughout the entire study, approximately during 5 years |
| Handgrip strength | Jamar dynamometer (in kg) | Throughout the entire study, approximately during 5 years |
| Physical activity | International Physical Activity Questionnaire (IPAQ) | Throughout the entire study, approximately during 5 years |
| Appetite | Simplified Nutritional Assessment Questionnaire (SNAQ). | Throughout the entire study, approximately during 5 years |
| UCLouvain | Not yet recruiting | Brussels | 1200 | Belgium |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013851 | Thinness |