| Trial ID: | L7231 |
| Source ID: | NCT03648554
|
| Associated Drug: |
Dulaglutide (Trulicity®) 1.5 Mg
|
| Title: |
Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST)
|
| Acronym: |
REALIST
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
DRUG: dulaglutide (TRULICITY®) 1.5 mg|OTHER: reinforced dietary monitoring
|
| Outcome Measures: |
Primary: Responder's proportion difference between the two groups (dulaglutide (TRULICITY®) on top of dietary reinforcement vs. dietary reinforcement alone), A responder is defined as having a histological improvement defined as the regression of non-alcoholic steatohepatitis (decrease of at least two points in the NASH Activity Score \[NAS\] measured on three components: steatosis, lobular inflammatory foci and hepatocyte ballooning) without worsening of fibrosis (defined by the stage of the Kleiner fibrosis classification) on liver histology obtained by liver puncture biopsy Score \> 4 = NASH confirmed Score 3-4 = borderline Score \< 3 = absence of NASH, after 52 weeks of treatment | Secondary: Fibrosis Kleiner score, Mean Changes in Kleiner score of fibrosis with distribution of patients into 3 groups according to the evolution of the score: improvement, stability or worsening., after 52 weeks of treatment|Fibrosis using Fibrotest score, Mean changes in Fibrotest measurement (six markers dosage: ALT, total bilirubin, GGT, Apolipoprotein A1, alpha2-macroglobulin, haptoglobin), after 52 weeks of treatment|Fibrosis marker parameter, Hyaluronic acid serum rate, after 52 weeks of treatment|Changes in serum levels of liver enzymes ALT and AST, ALT and AST levels, after 52 weeks of treatment|Changes in Lipid parameters, * LDL-cholesterol value * HDL-cholesterol value * Triglycerides value, after 52 weeks of treatment|Improvement in the glycemic control, Fasting glucose, after 52 weeks of treatment|overall glycemic control improvement, HbA1c, after 52 weeks of treatment|Change in body composition assessed by dual-energy x-ray absorptiometry scans, changes in fat mass, after 52 weeks of treatment|Change in quality of life, Quality of Life, Obesity and Diet Scale (QOLOD rating scale questionnaire).Items were grouped in 5 dimensions: physical impact, psycho-social impact, sexual impact, comfort with food, diet experience. Each item of the QOLOD questionnaire was graded from 1 to 5 (1: always/enormously; 2: often/a lot; 3: sometimes/moderately; 4: rarely/a little; 5: never/not at all). score was then calculated for each dimension by adding together its constituent items. Scores obtained by adding up answers graded from 1 to 5 of all items per dimension were transformed to convert the lowest and highest score possible to 0 and 100 respectively. Hence the higher the score, the better the quality of life., after 52 weeks of treatment|Change in weight, variation in weight between the beginning and the end of treatment, after 52 weeks of treatment|ALT and AST levels, The sustainability of dulaglutide (TRULICITY®) treatment on ALT and AST rates, At 24 weeks after completion of the treatment|Weight, The sustainability of dulaglutide (TRULICITY®) treatment on weight, At 24 weeks after completion of the treatment
|
| Sponsor/Collaborators: |
Sponsor: Central Hospital, Nancy, France | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
93
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-09-01
|
| Completion Date: |
2024-03-30
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| Results First Posted: |
|
| Last Update Posted: |
2019-06-25
|
| Locations: |
CHU de CAEN, Caen, 14033, France|CHU de DIJON, Dijon, 21079, France|Chu Marseille, Marseille, 13915, France|CHRU de MONTPELLIER, Montpellier, 34295, France|CHU de REIMS, Reims, 51092, France|CHU de ROUEN, Rouen, 76031, France|CHU de TOULOUSE, Toulouse, 31059, France|CHRU de NANCY, Vandœuvre-lès-Nancy, 54500, France|G.H.M les Portes du Sud, Venissieux, 69200, France
|
| URL: |
https://clinicaltrials.gov/show/NCT03648554
|
