| Trial ID: | L6510 |
| Source ID: | NCT04529278
|
| Associated Drug: |
Liraglutide
|
| Title: |
Efficacy and Tolerance of Liraglutide for Weight Loss in Obese Type 2 Diabetic Hemodialysis Patients
|
| Acronym: |
LIRADIAL
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Hemodialysis|Obese
|
| Interventions: |
DRUG: Liraglutide
|
| Outcome Measures: |
Primary: Weight Loss at Week 26, This outcome corresponds to 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., Week 26 | Secondary: Lift of CIT for transplant for obesity, This outcome corresponds to establish the number and percentage of patients whose CIT transplant for obesity will be lifted after 6 months of treatment., Week 26|Tolerance of luraglutide, This outcome corresponds to evaluate the number and percentage of serious and non-serious adverse events in type 2 diabetic patients on hemodialysis., Week 26|Regulation of blood sugar, This ouctome correspond to evaluate the reducing the number / dose of anti-diabetic drugs or the daily dose of insulin., Week 26|Glycemic balance, This ouctome correspond to compare the average variations in glycated hemoglobin (HbA1c) between M0 and M6., Week 26|Hypoglycemia, This ouctome correspond to evaluate the percentage of hypoglycaemia between Week 1 and Week 26., Week 26|Evolution of weight, This ouctome corresponds to evaluate the modifications of the dry mass and the fatty mass between M0 and M6 by bioimpedancemetry., Week 26|Therapeutic monitoring, This ouctome corresponds to evaluateconcentration of liraglutide before and after the dialysis session., Week 26
|
| Sponsor/Collaborators: |
Sponsor: Fondation Hôpital Saint-Joseph
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
18
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-01-18
|
| Completion Date: |
2023-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-04-14
|
| Locations: |
AURA Paris Plaisance, Paris, Groupe Hospitalier Paris Saint-Joseph, 75014, France|Groupe Hospitalier Paris Saint-Joseph, Paris, 75014, France|Hôpital Bichat, Paris, 75018, France|AURA Paris Site de Saint Ouen, Saint-Ouen, 93400, France
|
| URL: |
https://clinicaltrials.gov/show/NCT04529278
|
