Clinical trial NCT02418065: Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)
Official title: Multimodal Therapeutic Approach by Exercise, Oral Nutritional Supplementation, Omega 3 and Androgen in Undernourished Maintenance Hemodialysis Patients (AMERICANO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Kidney Failure
Keywords: Physical exercises
Oral nutritional supplementation
Multimodal
Hemodialysis
Protein-Energy Wasting
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Human Nutrition Research Center Rhône-Alpes
name: Société Francophone Nutrition Clinique et Métabolisme
name: Nutricia, Inc.
First posted: 2015-04-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.

Detailed description: The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.

Eligibility criteria: Inclusion Criteria:

* Hemodialysis patient since at least 6 month
* Patient aged 18 years or older
* Written consent to participate in the study
* No acute infection or hospitalization
* Opinion of Cardiologist saying there is no known evidence against the evaluation of the maximum exercise capacity
* Protein-energy wasting diagnosed if at least two of this characteristics are present
* Serum albumin \<3.8 g per 100 ml (Bromcresol Green)
* Serum prealbumin (transthyretin) \<30mg per 100 ml
* Reduce body mass (BMI \<23)
* Unintentional 10% weight loss over 6 months
* Lean body mass index \< 10th percentile

Exclusion Criteria:

* Presence of comorbidity which compromising the survival within 6 month
* Unintentional low DEI \<20 kcal kg_1 day_1
* HIV or HCV positive
* History of hormone dependent cancer
* Suspected or confirmed prostate cancer or breast carcinoma
* Known hypersensitivity for testosterone
* Presence or history of hepatic tumor
* Inability to follow the rehabilitation program
* Inadequate dialysis dosage (\<12 hours / week or Kt/V index\< 1,2) Pregnant or planning pregnancy and lactating women during study period
* Adult patient protected by law
* Patient who don't sign his informed consent

Primary outcomes:
measure: Change of physical endurance on bicycle
timeFrame: At months 3 and 15 after inclusion
Secondary outcomes:
measure: Transthyrin serum concentration evolution
timeFrame: at day 1
measure: Health-related quality of life assessment using SF-36 scale and KDQOL
timeFrame: at day 1
measure: Karnofsky score
timeFrame: at ady 1
measure: Maximal power on bicycle
timeFrame: at day 1
measure: Nutritional parameters
timeFrame: at day 1
measure: serum levels of albumin (g/L)
timeFrame: at day 1
measure: determination of urea (mmol/L)
timeFrame: at day 1
measure: determination of creatinine(µmol/L)
timeFrame: at 1 year
measure: Body composition
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Noël CANO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.