Trial · Interventional

TerminatedPhase 4Registry data

Effect of Liraglutide on Fatty Liver Content and Lipoprotein Metabolism

Short name LIRA-NAFLD/LIP

NCTNCT02721888Other idVERGES NOVO 2012

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Failure of inclusion

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 127 participants (actual)
Sponsor: Centre Hospitalier Universitaire Dijon · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
France
Start: 10 Jul 2012
Primary completion: 2 Oct 2019
Completion: Not stated
First posted: 29 Mar 2016 (estimated)
Last update posted: 6 Feb 2026
Conditions: Type 2 Diabetes

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20122014201620182020

Ph 4
LIRA-NAFLD/LIP
NCT02721888
10 Jul 2012 to 2 Oct 2019 (primary)
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Non-alcoholic fatty liver disease (NAFLD) is commonly associated with obesity, metabolic syndrome and type 2 diabetes. NAFLD, in patients with type 2 diabetes, has been shown to be associated with lipid abnormalities (such as hypertriglyceridemia and decreased HDL-cholesterol) and increased cardiovascular risk. Such lipid abnormalities (hypertriglyceridemia and decreased HDL-cholesterol) are very frequent in patients with type 2 diabetes. Moreover, NAFLD is a risk for further development of cirrhosis (estimated between 3 and 5%). Animal studies have shown that liraglutide is able to decrease liver fat content, but the effect of liraglutide on liver fat content in patients with diabetes remains unknown. In addition, human studies with liraglutide have shown significant modification of plasma lipids, such as reduction of plasma triglycerides and LDL-cholesterol. However, the mechanisms responsible for these liraglutide induced lipid modifications are not yet known. Because increased in liver fat content and hypertriglyceridemia are associated in patients with type 2 diabetes, it seems interesting to study the effect of liraglutide on both liver fat content and lipid metabolism using gold-standard methods (proton-spectroscopy for liver fat content assessment and kinetic study with stable isotope to study lipoprotein metabolism). This is a monocentric study. Fatty liver content will be performed by proton-spectroscopy in patients with type 2 diabetes (n=120) before and after a 6 month period of liraglutide therapy (1.2 mg/day). Moreover, an in vivo kinetic study will be performed with stable isotopes (13C leucine) in 10 patients among the 120 patients with type 2 diabetes (n=10) before and after a 6-month period of liraglutide (1.2 mg/day) therapy. Each kinetic study will be performed during a 2-day hospitalization For the main study, 3 visits will be performed: * a first visit at T0, before starting the treatment with liraglutide, including clinical and biological measurements and liver fat content assessment by proton-spectroscopy * a visit at 3 months including clinical and biological measurements * and a visit at 6 months including clinical and biological measurements and liver fat content assessment by proton-spectroscopy For the kinetic substudy, performed in 10 patients, a kinetic study with stable isotope will been performs during a 48h-hospitalization before starting the treatment with liraglutide and after 6 month-treatment with liraglutide

Interventions

LiraglutideDrug
MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)Drug
Blood sampleBiological
Kinetic substudy (10 patients)Other

Arms1

Experimental
Main study

Primary outcomes11

Outcomes the sponsor listed as primary.

Effect of liraglutide on fatty liver content evaluated by proton-spectroscopy (1H-spectroscopy and lipoprotein kinetics, in patients with type 2 diabetes
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Effects of liraglutide on Very Low Density Lipoprotein 1 (VLDL1) apolipoprotein B (apoB) production rate
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Effects of liraglutide on Very Low Density Lipoprotein 2 (VLDL2) apolipoprotein B (apoB) production rate
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Effects of liraglutide on Intermediate Density Lipoprotein (IDL) apolipoprotein B (apoB) production rate
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Effects of liraglutide on Low Density Lipoprotein (LDL) apolipoprotein B (apoB) production rate
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Effects of liraglutide on High Density Lipoprotein (HDL) apolipoprotein A1 (apoA1) production rate
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Effects of liraglutide on Very Low Density Lipoprotein 1 (VLDL1) apolipoprotein B (apoB) fractional catabolic rate
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Effects of liraglutide on Very Low Density Lipoprotein 2 (VLDL2) apolipoprotein B (apoB) fractional catabolic rate
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Effects of liraglutide on Intermediate Density Lipoprotein (IDL) apolipoprotein B (apoB) fractional catabolic rate
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Effects of liraglutide on Low Density Lipoprotein (LDL) apolipoprotein B (apoB) fractional catabolic rate
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Effects of liraglutide on High Density Lipoprotein (HDL) apolipoprotein A1 (apoA1) fractional catabolic rate
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)

Secondary outcomes(3)

Modification of body weight
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Registry description
Modification of weight, induced by liraglutide 1.2 mg/d therapy.
Modification of subcutaneous fat by Magnetic Resonance Imaging (MRI)
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Registry description
Modification of subcutaneous fat by MRI induced by liraglutide 1.2mg/d therapy
Modification of visceral fat by Magnetic Resonance Imaging (MRI)
Time frame · Before and after 6 month-treatment with liraglutide (1.2 mg/day)
Registry description
Modification of visceral fat by MRI induced by liraglutide 1.2mg/d therapy

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

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2018

7 results

Liraglutide Reduces Postprandial Hyperlipidemia by Increasing ApoB48 (Apolipoprotein B48) Catabolism and by Reducing ApoB48 Production in Patients With Type 2 Diabetes Mellitus.

Vergès et al. 2018Arteriosclerosis, thrombosis, and vascular biologycited by 60

PMID 30026275DOI 10.1161/atvbaha.118.310990PUB-30026275

Rights unknown7 results

Source link See results (7)

More studies

2 studies on this page

PubMed tag: none · 2023

Liraglutide reduces plasma dihydroceramide levels in patients with type 2 diabetes.

Denimal et al. 2023Cardiovascular diabetologycited by 23

PMID 37143040PMC10158384DOI 10.1186/s12933-023-01845-0PUB-37143040

CC BY

Download PDF

PubMed tag: none · 2021

Liraglutide Increases the Catabolism of Apolipoprotein B100-Containing Lipoproteins in Patients With Type 2 Diabetes and Reduces Proprotein Convertase Subtilisin/Kexin Type 9 Expression.

Vergès et al. 2021Diabetes carecited by 47

PMID 33531418DOI 10.2337/dc20-1843PUB-33531418

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Patients with type 2 diabetes * Patients treated by metformin and/or sulfonylureas (or glinides) and/or acarbose and/or insulin, * HbA1C \>= 7 %, * Patients who gave their written consent. For the kinetic substudy: * Patients who have the typical features of diabetic dyslipidemia (triglycerides \>= 1.50 g/l and/or HDL\<0.50 g/l \[women\], 0.40 g/l \[men\]) Exclusion Criteria: * Treatment with thiazolidinediones or other Glucagon-like peptide-1(GLP1) agonist. * No treatment with a Dipeptidyl peptidase-4 (DPP4) inhibitor during the 3 previous months, * Renal or hepatic failure, * Contra-indication for proton-spectroscopy (pacemaker, implantable prosthesis,..), * Pregnancy. For the kinetic substudy: * Patients on hypolipidemic agents

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