Status:
COMPLETED
The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
Göteborg University
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
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 nov...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT02765399
Start Date
February 1 2015
End Date
February 28 2019
Last Update
April 12 2022
Active Locations (1)
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1
Helsinki University Central Hospital
Helsinki, Finland, 00029