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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-01

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Liraglutide

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Victoza

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No