Trial · Interventional
Status unknownPhase 4Registry dataResearching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST)
Short name REALIST
Overview
- Status
- Status unknown
- Phase
- Phase 4
- Enrollment
- 93 participants (estimated)
- Sponsor
- Central Hospital, Nancy, France · Other
- Design
- Randomized · Single masking
- Countries
1 country
France
- Start
- 1 Sept 2019 (estimated)
- Primary completion
- 30 Sept 2023 (estimated)
- Completion
- 30 Mar 2024 (estimated)
- First posted
- 27 Aug 2018
- Last update posted
- 25 Jun 2019
- Conditions
- Diabetes Mellitus, Type 2 · NASH - Nonalcoholic Steatohepatitis
Timeline
1 trial
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
GLP-1 analogues represent new treatments in diabetes that cause weight loss. Their effect on NASH in humans is unknown. A decrease in Alanine Aminotransferase (ALT) has been reported in pooled Exenatide/Placebo and Liraglutide/Placebo studies. More recently, LEAN study has shown that Liraglutide will result in improvements in liver histology in patients with NASH. It should be of high interest to investigate the effect of another GLP-1 Agonist as effective as Liraglutide, i.e. Dulaglutide in NASH. Dulaglutide is one of the five GLP-1 receptor agonists approved for type 2 diabetes mellitus (T2DM). It is an effective treatment because it is dosed once-weekly, provides HbA1c reduction similar to Liraglutide, weight reduction similar to Exenatide, and has an adverse effect profile similar to other GLP-1 receptor agonists. Reduction in body weight was observed in patients treated with Dulaglutide, irrespective of nausea and/or vomiting.The search for a direct effect of Dulaglutide on liver fat overload in patients with type2 diabetes is required before considering the effectiveness of this treatment in NASH in diabetic populations. No current GLP-1 study has been designed with a control group with the same weight loss than as in the treatment group. Primary objective: The investigators aim to study the effect of Dulaglutide 1.5 mg (TRULICITY®) add-on to dietary reinforcement after 52 weeks of treatment, on the improvement of liver histology compared to dietary reinforcement alone in patients with type 2 diabetes and carriers of non-alcoholic steatohepatitis. Secondary objectives: * After 52 weeks of treatment, to assess the effect of dulaglutide (TRULICITY®) add-on to dietary reinforcement on Fibrosis score, Transaminase levels, body composition as measured by dual energy X-ray absorptiometry, lipid profile, glycemic control and weight. The effect of the treatment will also be assessed on quality of life. * At 24 weeks after completion of the treatment, to assess the sustainability of dulaglutide (TRULICITY®) treatment add-on to dietary reinforcement on ALT and AST rates as well as on weight.
Interventions
- dulaglutide (TRULICITY®) 1.5 mgDrug
- reinforced dietary monitoringOther
Arms2
Experimental
dulaglutide (TRULICITY®) 1.5 mg
dulaglutide (TRULICITY®) subcutaneous administration, one weekly injection, in a dose of 1.5 mg of dulaglutide for 52 weeks in combinaison with reinforced dietary monitoring as same as control group.
Sham comparator
reinforced dietary monitoring
reinforced dietary monitoring with frequent dietary consultations, based on American Heart Association (AHA) recommendations
Primary outcomes1
Outcomes the sponsor listed as primary.
Responder's proportion difference between the two groups (dulaglutide (TRULICITY®) on top of dietary reinforcement vs. dietary reinforcement alone)
Time frame · after 52 weeks of treatment
Registry description
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
Secondary outcomes(12)
Fibrosis Kleiner score
Time frame · after 52 weeks of treatment
Registry description
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.
Fibrosis using Fibrotest score
Time frame · after 52 weeks of treatment
Registry description
Mean changes in Fibrotest measurement (six markers dosage: ALT, total bilirubin, GGT, Apolipoprotein A1, alpha2-macroglobulin, haptoglobin)
Fibrosis marker parameter
Time frame · after 52 weeks of treatment
Registry description
Hyaluronic acid serum rate
Changes in serum levels of liver enzymes ALT and AST
Time frame · after 52 weeks of treatment
Registry description
ALT and AST levels
Changes in Lipid parameters
Time frame · after 52 weeks of treatment
Registry description
* LDL-cholesterol value * HDL-cholesterol value * Triglycerides value
Improvement in the glycemic control
Time frame · after 52 weeks of treatment
Registry description
Fasting glucose
overall glycemic control improvement
Time frame · after 52 weeks of treatment
Registry description
HbA1c
Change in body composition assessed by dual-energy x-ray absorptiometry scans
Time frame · after 52 weeks of treatment
Registry description
changes in fat mass
Change in quality of life
Time frame · after 52 weeks of treatment
Registry description
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.
Change in weight
Time frame · after 52 weeks of treatment
Registry description
variation in weight between the beginning and the end of treatment
ALT and AST levels
Time frame · At 24 weeks after completion of the treatment
Registry description
The sustainability of dulaglutide (TRULICITY®) treatment on ALT and AST rates
Weight
Time frame · At 24 weeks after completion of the treatment
Registry description
The sustainability of dulaglutide (TRULICITY®) treatment on weight
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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