Cachexia, Chronic Kidney Diseases
Conditions
Keywords
cachexia, Protein energy wasting, microbiota, chronic kidney disease, dialysis
Brief summary
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: 1. Set up a prospective cohort of deeply characterized kidney failure patients treated with hemodialysis (in-center, self-care dialysis in a satellite unit and at home) and peritoneal dialysis, including evaluation of cachexia, body composition, collection of feces and blood to characterize the gut microbiota, measure serum levels of uremic toxins and inflammatory markers, with a longitudinal follow-up. 2. To compare cachectic versus non-cachectic dialysis patients in terms of gut microbiota, inflammatory markers, level of uremic toxins, muscle transcriptome, dialysis dose and modality. In a subgroup analysis, the investigators plan to compare the different techniques of dialysis (in-center vs home-hemodialysis vs peritoneal dialysis).
Interventions
OTHERCollection of clinical data and biological sampling
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.
Sponsors
Fonds National de la Recherche Scientifique
FRC- Fonds de la Recherche Clinique
SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation
Université Catholique de Louvain
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Diagnosis of kidney failure (stage V) * Maintenance dialysis for at least 3 months * Understanding of the trial procedures and ability to adhere to the trial protocol
Exclusion criteria
* Severe nonadherence to the dialysis procedure * Life expectancy below 1 year * Chronic inflammatory disease of the digestive tract (Crohn's disease, ulcerative colitis) * Bariatric surgery * Active cancer * Pregnancy * Antibiotics consumption in the month preceding the inclusion * Gastro-intestinal surgery, colonoscopy, or probiotics consumption in the 3 months preceding the inclusion * Drugs influencing body composition initiated ≤ 1 month : systemic corticosteroids, anabolic drugs as insulin or testosterone, post-menopausal hormone therapy, injectable contraceptives. * Known endocrinological disorders potentially leading to hypo- or hypermetabolism, untreated or treated for ≤ 1 month : disorders of thyroid gland, adrenal glands... * Patients under weight loss drugs : GLP1 agonists, orlistat
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composition and function of the gut microbiota | Throughout the entire study, approximately during 5 years | Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition and function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of uremic toxins | Throughout the entire study, approximately during 5 years | — |
| Metabolomics profile | Throughout the entire study, approximately during 5 years | — |
| Dialysis dose | Throughout the entire study, approximately during 5 years | number of hours of dialysis per week |
| Dialysis modality | Throughout the entire study, approximately during 5 years | in-center hemodialysis vs self-care dialysis in a satellite unit vs home-hemodialysis vs peritoneal dialysis |
| Level of inflammatory markers | Throughout the entire study, approximately during 5 years | — |
| Quality of life | Throughout the entire study, approximately during 5 years | FAACT (Functional Assessment of Anorexia-Cachexia Therapy) and FACIT (Functional Assessment of Chronic Illness Therapy - Fatigue Scale) questionnaires |
| Handgrip strength | Throughout the entire study, approximately during 5 years | Jamar dynamometer (in kg) |
| Physical activity | Throughout the entire study, approximately during 5 years | International Physical Activity Questionnaire (IPAQ) |
| Appetite | Throughout the entire study, approximately during 5 years | Simplified Nutritional Assessment Questionnaire (SNAQ). |
| Body composition | Throughout the entire study, approximately during 5 years | Bioelectrical impedance analysis (in kg) |
Countries
Belgium
Contacts
Primary ContactLaure Bindels, PhD
Backup ContactEric Goffin, MD
Outcome results
None listed