Effect of Liraglutide on lipid synthesis and metabolism after mixed meal. A single-center randomized controlled study.

The effect of Liraglutide treatment on postprandial chylomicron and VLDL kinetics, liver fat and de novo lipogenesis. A single-center randomized controlled study. - LIRA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005075-40-FI

Enrollment

Registered

2014-02-03

Start date

2014-04-08

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Trade Name: Liraglutide Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Concentration unit: mg/ml milligram(s)/millilitre Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Obese subjects with T2D and a large waist (waist > 88 cm in women and > 92 cm in men, BMI 27–40 kg/m2, triglycerides between 1.0 – 4.0 mmol/L and LDL =65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: ? Type 1 diabetes ? Apo E2/2 phenotype ? ALT/AST > 3x ULN ? GFR 25 mg / day) within 6 months ? 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to elucidate the mechanisms underlying the positive effect of incretin therapy on lipoprotein metabolism, liver fat and cardiovascular risk markers. 1) To examine the effect of liraglutide on triglycerides (TG) and apoB48 production rates (PR) and/or fractional catabolic rates (FRC) in the lipoprotein fraction chylomicrons (Sf>400) in patients with T2DM. This will be fulfilled by kinetic modeling during a standardized fat-rich mixed-meal test. 2) To evaluate the in humans the effect of treatment with liraglutide compared to baseline on hepatic de novo lipogenesis and liver fat content in patients with T2DM, assessed during a standardized fat-rich mixed meal test. ;Secondary Objective: To evaluate the effect of treatment with liraglutide compared to baseline in patients with T2DM, assessed during a standardized fat-rich mixed-meal test combined with stable isotope administration on: -production rates (PR) of TG, apo-B48 and apo-B100 in the lipoprotein fractions VLDL1 (Sf 60–400) and VLDL2 (Sf 20–60) -fractional catabolic rates (FCRs) of TG, ap-B48 and apo-B100 in the lipoprotein fraction VLDL1 (Sf 60–400) and VLDL2 (sf 20–60) -fasting and postprandial serum total TG, total cholesterol, and total apo-B, apo-B48, RLP-chol and RLP-TG, apo-CIII and apo-A5 as well as fasting LDL and HDL size. RLP-chol and RLP-TG are surrogate markers of remnants. Apo-CIII and apo-A5 are key regulators of the lipolytic cascade. -TRL clearance assessed as effect on post-heparin lipoprotein lipase (LPL) and hepatic lipase (HL) activities. LPL and HL are the key enzymes regulating lipolysis of TRLs and remnant removal by the liver. - fasting and postprandial glucose, insulin and C-pept;Primary end point(s): 1) effect of liraglutide on triglycerides (TG) and apoB48 production rates (PR) and/or fractional catabolic rates (FRC) in the lipoprotein fraction chylomicrons (Sf>400) in patients with T2DM. This will be fulfilled by kinetic modeling during a st	—

Measure

Time frame

Main Objective: The aim of this study is to elucidate the mechanisms underlying the positive effect of incretin therapy on lipoprotein metabolism, liver fat and cardiovascular risk markers. 1) To examine the effect of liraglutide on triglycerides (TG) and apoB48 production rates (PR) and/or fractional catabolic rates (FRC) in the lipoprotein fraction chylomicrons (Sf>400) in patients with T2DM. This will be fulfilled by kinetic modeling during a standardized fat-rich mixed-meal test. 2) To evaluate the in humans the effect of treatment with liraglutide compared to baseline on hepatic de novo lipogenesis and liver fat content in patients with T2DM, assessed during a standardized fat-rich mixed meal test. ;Secondary Objective: To evaluate the effect of treatment with liraglutide compared to baseline in patients with T2DM, assessed during a standardized fat-rich mixed-meal test combined with stable isotope administration on: -production rates (PR) of TG, apo-B48 and apo-B100 in the lipoprotein fractions VLDL1 (Sf 60–400) and VLDL2 (Sf 20–60) -fractional catabolic rates (FCRs) of TG, ap-B48 and apo-B100 in the lipoprotein fraction VLDL1 (Sf 60–400) and VLDL2 (sf 20–60) -fasting and postprandial serum total TG, total cholesterol, and total apo-B, apo-B48, RLP-chol and RLP-TG, apo-CIII and apo-A5 as well as fasting LDL and HDL size. RLP-chol and RLP-TG are surrogate markers of remnants. Apo-CIII and apo-A5 are key regulators of the lipolytic cascade. -TRL clearance assessed as effect on post-heparin lipoprotein lipase (LPL) and hepatic lipase (HL) activities. LPL and HL are the key enzymes regulating lipolysis of TRLs and remnant removal by the liver. - fasting and postprandial glucose, insulin and C-pept;Primary end point(s): 1) effect of liraglutide on triglycerides (TG) and apoB48 production rates (PR) and/or fractional catabolic rates (FRC) in the lipoprotein fraction chylomicrons (Sf>400) in patients with T2DM. This will be fulfilled by kinetic modeling during a st

—

Secondary

Measure	Time frame
Secondary end point(s): The effect of treatment with liraglutide compared to baseline in patients with T2DM, assessed during a standardized fat-rich mixed-meal test combined with stable isotope administration on: -production rates (PR) of TG, apo-B48 and apo-B100 in the lipoprotein fractions VLDL1 (Sf 60–400) and VLDL2 (Sf 20–60) -fractional catabolic rates (FCRs) of TG, ap-B48 and apo-B100 in the lipoprotein fraction VLDL1 (Sf 60–400) and VLDL2 (sf 20–60) -fasting and postprandial serum total TG, total cholesterol, and total apo-B, apo-B48, RLP-chol and RLP-TG, apo-CIII and apo-A5 as well as fasting LDL and HDL size. RLP-chol and RLP-TG are surrogate markers of remnants. Apo-CIII and apo-A5 are key regulators of the lipolytic cascade. -TRL clearance assessed as effect on post-heparin lipoprotein lipase (LPL) and hepatic lipase (HL) activities. LPL and HL are the key enzymes regulating lipolysis of TRLs and remnant removal by the liver. -fasting and postprandial glucose, insulin and C-peptide, assessed also during an OGTT. -fasting visceral andsubcutaneous fat depots assessed by MRS in both fasting and in postprandial period. ;Timepoint(s) of evaluation of this end point: baseline vs 3.5 months after treatment	—

Measure

Time frame

Secondary end point(s): The effect of treatment with liraglutide compared to baseline in patients with T2DM, assessed during a standardized fat-rich mixed-meal test combined with stable isotope administration on: -production rates (PR) of TG, apo-B48 and apo-B100 in the lipoprotein fractions VLDL1 (Sf 60–400) and VLDL2 (Sf 20–60) -fractional catabolic rates (FCRs) of TG, ap-B48 and apo-B100 in the lipoprotein fraction VLDL1 (Sf 60–400) and VLDL2 (sf 20–60) -fasting and postprandial serum total TG, total cholesterol, and total apo-B, apo-B48, RLP-chol and RLP-TG, apo-CIII and apo-A5 as well as fasting LDL and HDL size. RLP-chol and RLP-TG are surrogate markers of remnants. Apo-CIII and apo-A5 are key regulators of the lipolytic cascade. -TRL clearance assessed as effect on post-heparin lipoprotein lipase (LPL) and hepatic lipase (HL) activities. LPL and HL are the key enzymes regulating lipolysis of TRLs and remnant removal by the liver. -fasting and postprandial glucose, insulin and C-peptide, assessed also during an OGTT. -fasting visceral andsubcutaneous fat depots assessed by MRS in both fasting and in postprandial period. ;Timepoint(s) of evaluation of this end point: baseline vs 3.5 months after treatment

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Countries

Finland

Contacts

Public ContactClinical trials information

Research Programs' Unit, Diabetes & Obesity, University of Helsinki

tiimi.taskinen@hus.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026