obese type 2 diabetic hemodialysis patients
Conditions
Interventions
Trade Name: Liraglutide
Product Name: Liraglutide
Pharmaceutical Form: Injection
Sponsors
Groupe Hospitalier Paris Saint-Joseph
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient aged = 18 and 30 kg / m2 with a Temporary Contraindication for kidney transplant for renal transplant due to overweight by his graft center - Patient affiliated to a health insurance plan - French speaking patient - Patient having given free, informed and written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Patient with a Temporary Contraindication for kidney transplant for a cause other than overweight - Patient with personal or family history of thyroid medullary cancer - Patient with a history of acute or chronic pancreatitis - Patient who has already had hypersensitivity to liraglutide (or to any other component of the product) - Patient who has already had a severe digestive intolerance to taking GLP-1 receptor agonists (such as exenatide or lixisenatide) - Patient already included in an interventional risk research protocol (RIPH1) - Pregnant or lactating woman - Patient under guardianship or curatorship - Patient deprived of liberty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess weight loss in obese diabetic patients on hemodialysis after 6 months of treatment with liraglutide in order to facilitate access to renal transplants for patients who have been rejected for being overweight;Secondary Objective: The secondary objectives correspond to: - establish the number and percentage of patients whose CIT transplant for obesity will be lifted after 6 months of treatment - study the tolerance of liraglutide in type 2 diabetic patients on hemodialysis - assess the impact of liraglutide on the treatment already in place to regulate blood sugar - evaluate the modifications of the glycemic balance under liraglutide between M0 and M6 - assess the percentage of hypoglycaemia during the day using the free freestyle pro sensors - evaluate the modifications of the dry mass and the fatty mass between M0 and M6 - evaluate the therapeutic monitoring of patients before and after the dialysis session;Primary end point(s): weight loss (in kg) after 6 months of treatment with liraglutide.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The criteria for secondary judgments correspond to: - the number and percentage of patients whose BMI is <30 kg / m2 after treatment and for whom the transplant weight contraindication is removed - the number and percentage of serious and non-serious adverse events in patients with type 2 diabetes on hemodialysis - the decrease in the number / dose of anti-diabetic drugs or the daily insulin dose - comparison of the average variations of glycated hemoglobin (HbA1c) between M0 and M6 - the frequency of hypoglycaemia during the day in all patients via free freestyle pro sensors - comparison of variations in the percentage of dry mass and fat mass between M0 and M6 - the concentration of liraglutide before and after the dialysis session;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
France
Contacts
Public ContactClinical Research project manager
Groupe Hospitalier Paris Saint-Joseph
Outcome results
None listed