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
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Liraglutide Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
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.
- Change in liver fat content [ Time Frame: 4 months ]
- 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
- Change in hepatic de novo lipogenesis [ Time Frame: 4 months ]
- ApoB100/apoB48 kinetics [ Time Frame: 4 months ]Before vs. after intervention: apoB100/apoB48 secretion rate
- ApoB100/apoB48 kinetics [ Time Frame: 4 months ]Before vs. after intervention: apoB100/apoB48 fractional catabolic rate
- Metabolic parameters [ Time Frame: 4 months ]Before vs. after intervention: postprandial lipids and apolipoproteins (8 hours) after oral fat tolerance test
- Metabolic parameters [ Time Frame: 4 months ]Before vs. after intervention: glycemic control
- Metabolic parameters [ Time Frame: 4 months ]Before vs. after intervention: plasma lipidomics
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
|Helsinki University Central Hospital|
|Helsinki, Finland, 00029|
|Principal Investigator:||Niina Matikainen, MD, PhD||Senior Endocrinologist|