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Trial record 32 of 396 for:    LIRAGLUTIDE

The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis

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ClinicalTrials.gov Identifier: NCT02765399
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Niina Matikainen, Helsinki University Central Hospital

Brief Summary:
This study aims to evaluate the mechanisms underlying the effect of incretin therapy on lipoprotein metabolism in subjects with type 2 diabetes and to study the effect of liraglutide on hepatic de novo lipogenesis.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Liraglutide Drug: Placebo Phase 4

Detailed Description:

The well recognized dyslipidemia in people with type 2 diabetes consists of high fasting and non-fasting plasma triglycerides (TG), low high-density lipoprotein (HDL) -cholesterol and preponderance of small dense low-density lipoprotein (LDL) particles nominated as the atherogenic lipid triad. Humans are mostly in a postprandial rather than fasting state and therefore non-fasting TG values reflect more accurately the continuous exposure of arterial wall to triglyceride rich lipoproteins (TRLs) and more importantly, to substantial cholesterol load that these particles deliver.

Postprandial lipemia is highly prevalent even in type 2 diabetes patients with normal fasting TG concentrations. Intestinal overproduction of chylomicrons (CMs) and the structural protein apolipoprotein (apo)-B48 has been identified as an integral feature of postprandial lipemia in type 2 diabetes and insulin resistance. It is clinically important to elucidate the mechanism for delayed postprandial lipemia and the interactions between dysglycemia and dyslipidemia in type 2 diabetes patients.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis - a Single-center Randomized Controlled Study
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide

Liraglutide subcutaneous injection once daily with following dose escalation:

liraglutide 0.6 mg once daily for one week; liraglutide 1.2 mg once daily for one week and thereafter liraglutide 1.8 mg once daily for 3.5 months.

Drug: Liraglutide
Other Name: Victoza

Placebo Comparator: Placebo

Placebo subcutaneous injection once daily with following dose escalation:

placebo 0.1 ml once daily for one week; placebo 0.2 ml once daily for one week and thereafter placebo 0.3 ml once daily for 3.5 months.

Drug: Placebo



Primary Outcome Measures :
  1. Change in liver fat content [ Time Frame: 4 months ]
  2. Plasma triglyceride (TG) area under curve (AUC) [ Time Frame: 4 months ]
    Before vs after intervention: postprandial plasma TG summary measure expressed as AUC (baseline to 8 hours) after oral fat tolerance test


Secondary Outcome Measures :
  1. Change in hepatic de novo lipogenesis [ Time Frame: 4 months ]
  2. ApoB100/apoB48 kinetics [ Time Frame: 4 months ]
    Before vs. after intervention: apoB100/apoB48 secretion rate

  3. ApoB100/apoB48 kinetics [ Time Frame: 4 months ]
    Before vs. after intervention: apoB100/apoB48 fractional catabolic rate

  4. Metabolic parameters [ Time Frame: 4 months ]
    Before vs. after intervention: postprandial lipids and apolipoproteins (8 hours) after oral fat tolerance test

  5. Metabolic parameters [ Time Frame: 4 months ]
    Before vs. after intervention: glycemic control

  6. Metabolic parameters [ Time Frame: 4 months ]
    Before vs. after intervention: plasma lipidomics



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes treated with a lifestyle or metformin (any dose)
  • waist circumference > 88 cm in women and > 92 cm in men
  • BMI 27-40 kg/m2
  • triglycerides between 1.0 - 4.0 mmol/L
  • LDL < 4.5 mmol/l

Exclusion Criteria:

  • Type 1 diabetes
  • Apo E2/2 phenotype
  • ALT/AST > 3x ULN
  • GFR < 60 ml/min, clinically significant TSH outside normal range
  • Lipid-lowering drugs other than statins within 6 months
  • Current treatment with pioglitazone, insulin, sulphonylureas, gliptins, glinides, SGLT-2 inhibitors or thiazide diuretics (at a dose of > 25 mg / day)
  • Blood pressure > 160 mmHg systolic and/or > 105 diastolic
  • History of pancreatitis or stomach / other major bleeding, thyroid neoplasia, persistent hypothyroidism or persistent hyperthyroidism
  • Any medical condition that puts the patient in the risk of dehydration
  • Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
  • Females of childbearing potential who are not using adequate contraceptive methods
  • Subjects who have experienced side-effects previously from GLP-1 agonists
  • Non-compliance or withdrawal of consent
  • Any information or clinical event described in liraglutide SPC that is a contraindication for the use of liraglutide

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): NCT02765399


Locations
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Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Göteborg University
Investigators
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Principal Investigator: Niina Matikainen, MD, PhD Senior Endocrinologist

Publications of Results:
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Responsible Party: Niina Matikainen, Senior Endocrinologist, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02765399     History of Changes
Other Study ID Numbers: LIRA
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists