Sponsor study identifier
interventional
30
1 country
1
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2013
Actual (reported)The structural and functional alterations of high density lipoproteins (HDL) levels in type 2 diabetes (T2D) patients linked to hypertriglyceridemia, hyperglycemia, insulin resistance, inflammation and oxidation, play a major role in the increased macrovascular risk in these patients. An impaired function of the adipose tissue (AT) in T2D contributes to low HDL concentrations. Objectives: 1) Quantitative and qualitative characterisation of HDL subclasses by ultracentrifugation, proteomic and metabolomic techniques. 2) To study the relationship between the HDL subclasses, preβ1 HDL and remnant HDL, and clinical determinants of arteriosclerosis. 3) Functional in vitro studies of the HDL subclasses determined in Objective 1. 4) To study the role of AT determining the low HDL levels. 5) To study the impact of HDL increasing drugs on HDL qualitative changes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 2011
Actual (reported)December 2013
Actual (reported)May 26, 2014
Actual (reported)June 3, 2014
Actual (reported)HDL particles size and number assessed by nuclear magnetic resonance (NMR) and reported as nm and micromol/L
HDL particles were studied by NMR in T2D patients after treatment with fenofibrate or Niacin
Two periods of 12 weeks treatment according to crossing over design
Apolipoprotein A1 (Apo A1), apolipoprotein A2 (Apo A2), paraoxonase (PON) HDL concentration (g/l - mg/l)
Two periods of 12 weeks treatment according to crossing over design
Lecithin-cholesterol acyltransferase (LCAT) and cholesteryl ester transfer protein (CETP) activity (AU - pmol/h*μl) and mass (microg/ml)
Two periods of 12 weeks treatment according to crossing over design
Fenofibrate 145 mg/day for 12 weeks
Niacin 2g/day plus Laropiprant for 12 weeks
fenofibrate 145/day for 12 weeks
Niacin 2 g/day plus Laropiprant for 12 weeks
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Niacin plus laropiprant
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordHospital Universitari Sant Joan
Reus, Tarragona, 43204, Spain
Luis Masana, Professor
Institut Investigacio Sanitaria Pere Virgili
30 participants (actual enrollment reported by the registry).
First Submitted
May 26, 2014
First Posted
June 3, 2014
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Cinical Trial to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy
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Primary Completion
December 2011
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
June 3, 2014
Record last verified: 2014-05
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Source: ClinicalTrials.gov.
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