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Effect of Liraglutide on Fatty Liver Content and Lipoprotein Metabolism (LIRA-NAFLD/LIP)

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ClinicalTrials.gov Identifier: NCT02721888
Recruitment Status : Unknown
Verified February 2016 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : March 29, 2016
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Liraglutide Drug: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) Biological: Blood sample Other: Kinetic substudy (10 patients) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Liraglutide on Fatty Liver Content Evaluated by Proton-spectroscopy (1H-spectroscopy) and Lipoprotein Kinetic, in Patients With Type 2 Diabetes
Study Start Date : July 2012
Estimated Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Main study Drug: Liraglutide
Drug: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
Biological: Blood sample
Other: Kinetic substudy (10 patients)



Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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 Outcome Measures :
  1. Modification of body weight [ Time Frame: Before and after 6 month-treatment with liraglutide (1.2 mg/day) ]
    Modification of weight, induced by liraglutide 1.2 mg/d therapy.

  2. Modification of subcutaneous fat by Magnetic Resonance Imaging (MRI) [ Time Frame: Before and after 6 month-treatment with liraglutide (1.2 mg/day) ]
    Modification of subcutaneous fat by MRI induced by liraglutide 1.2mg/d therapy

  3. Modification of visceral fat by Magnetic Resonance Imaging (MRI) [ Time Frame: Before and after 6 month-treatment with liraglutide (1.2 mg/day) ]
    Modification of visceral fat by MRI induced by liraglutide 1.2mg/d therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721888


Contacts
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Contact: Bruno VERGES 03.80.29.34.53 ext 33 bruno.verges@chu-dijon.fr

Locations
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France
CHU de Dijon Recruiting
Dijon, France, 21079
Contact: Bruno VERGES    03.80.29.34.53 ext 33    bruno.verges@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02721888    
Other Study ID Numbers: VERGES NOVO 2012
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Fatty Liver
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists