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Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients (GREFFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02859506
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

Today, we know that olfactogustatory alterations occur in cirrhotic patients before the liver transplant but no study has been conducted to show eventual disturbances after the transplantation able to explain modifications in eating behaviour. In parallel, the metabolic status, itself dependent on liver metabolism, influences food preferences and is modified after the transplantation as the liver recovers its ability to store glycogen, but is not able to inform the brain as the afferent nerve impulses have been suppressed. The innovative aspect of this project is to provide information on the importance of the liver in the regulation of energy homeostasis.

The results of this study will improve our understanding of eating behaviour and olfactogustatory sensitivity and allow us to orient liver transplant patients towards appropriate diets.


Condition or disease Intervention/treatment Phase
Eating Behaviour Liver Transplant Other: Respiratory quotient Other: Olfactory liking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients
Study Start Date : July 2015
Estimated Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: liver transplant Other: Respiratory quotient
Other: Olfactory liking
Active Comparator: kidney transplant Other: Respiratory quotient
Other: Olfactory liking
Placebo Comparator: control Other: Respiratory quotient
Other: Olfactory liking



Primary Outcome Measures :
  1. Change in respiratory quotient (RQ) by indirect calorimetry compared with baseline values [ Time Frame: At month 0, month 3, month 6 and month 9 ]

Secondary Outcome Measures :
  1. Change in olfactory liking compared with baseline values by questionnaire [ Time Frame: At month 0, month 3, month 6 and month 9 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • persons who have provided written informed consent
  • persons aged between 18 and 60 years
  • persons waiting for a liver transplantation (group LT)
  • persons waiting for a kidney transplantation (KT)
  • healthy subjects (control group) no known disease

Exclusion Criteria:

  • persons without national health insurance cover
  • persons with chronic infection,
  • persons with acute infection,
  • persons with progressive cancer,
  • persons with an antibiotic treatment,
  • persons who drink alcohol,
  • pregnant or breast-feeding women,
  • persons with an aversion to the foods proposed in the study,
  • persons taking treatments known to interfere with gustatory and olfactory performance,
  • adults under guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859506


Contacts
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Contact: Laurent BRONDEL 03.80.29.34.84 ext +33 laurent.brondel@chu-dijon.fr

Locations
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France
Centre Hospitalier Universitaire Recruiting
Dijon, France, 21079
Contact: Laurent BRONDEL    06 77 10 86 53 ext 33    laurent.brondel@u-bourgogne.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02859506     History of Changes
Other Study ID Numbers: BRONDEL INRA 2013
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: July 2016