Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO) (AMERICANO)

July 28, 2016 updated by: University Hospital, Clermont-Ferrand

Multimodal Therapeutic Approach by Exercise, Oral Nutritional Supplementation, Omega 3 and Androgen in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand
        • Sub-Investigator:
          • Myriam ISNARD
        • Sub-Investigator:
          • Didier AGUILERA
        • Sub-Investigator:
          • Didier DUCLOUX
        • Sub-Investigator:
          • Christophe MARIAT
        • Sub-Investigator:
          • Dorothée BAZIN KARA
        • Sub-Investigator:
          • Anne-Elizabeth HENG
        • Sub-Investigator:
          • Fitsum GUEBREEGZIABHE
        • Sub-Investigator:
          • Denis FOUQUE
        • Sub-Investigator:
          • Atman HADDJELMRABET
        • Sub-Investigator:
          • Eric LARUELLE
        • Sub-Investigator:
          • Charles CHAZOT
        • Sub-Investigator:
          • Abdallah GUERRAOUI
        • Sub-Investigator:
          • Prisca MUTINELLI
        • Sub-Investigator:
          • Hélène DE PRENEUF
        • Sub-Investigator:
          • François MAURICE
        • Sub-Investigator:
          • Pedro PALACIN
        • Sub-Investigator:
          • Daniel TETA
        • Sub-Investigator:
          • Marie ESSIG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treated group
testosteron, oral nutritional supplementation, n3 polyunsaturated fatty acid, training on ergonomic bicycle
Drug: Testosterone
Other: training on ergonomic bicycle
Drug: Oral nutritional supplementation
Drug: n3 polyunsaturated fatty acid
Other: control group
oral nutritional supplementation
Drug: Oral nutritional supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of physical endurance on bicycle
Time Frame: At months 3 and 15 after inclusion
Physical endurance on bicycle at intermediate power between maximal power and ventilatory threshold power (Pmax+Pthreshold)/2
At months 3 and 15 after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transthyrin serum concentration evolution
Time Frame: at day 1
(Unit of Measure: g/L)
at day 1
Health-related quality of life assessment using SF-36 scale and KDQOL
Time Frame: at day 1
at day 1
Karnofsky score
Time Frame: at ady 1
at ady 1
Maximal power on bicycle
Time Frame: at day 1
Unit of Measure: Watt
at day 1
Nutritional parameters
Time Frame: at day 1
weight (Kg)
at day 1
serum levels of albumin (g/L)
Time Frame: at day 1
at day 1
determination of urea (mmol/L)
Time Frame: at day 1
at day 1
determination of creatinine(µmol/L)
Time Frame: at 1 year
at 1 year
Body composition
Time Frame: at day 1
(evaluated by bioimpedance)
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Nutricia, Inc.
Société Francophone Nutrition Clinique et Métabolisme
Human Nutrition Research Center Rhône-Alpes

Investigators

  • Principal Investigator: Noël CANO, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

April 3, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0231

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Failure

Clinical Trials on Testosterone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe