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

• Status: Completed
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinki University Central Hospital
• Collaborator: Göteborg University
• Treatments: Liraglutide

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