Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment (LOWHDL)
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ClinicalTrials.gov Identifier: NCT02153879 |
Recruitment Status :
Completed
First Posted : June 3, 2014
Last Update Posted : June 3, 2014
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus Dyslipidemia | Drug: Fenofibrate Drug: Niacin plus laropiprant | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Qualitative and Quantitative Characterization of HDL in T2D After Fenofibrate or Niacin Treatment in Spanish Population |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Fenofibrate
Fenofibrate 145 mg/day for 12 weeks
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Drug: Fenofibrate
fenofibrate 145/day for 12 weeks
Other Name: Secalip |
Experimental: Niacin plus Laropiprant
Niacin 2g/day plus Laropiprant for 12 weeks
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Drug: Niacin plus laropiprant
Niacin 2 g/day plus Laropiprant for 12 weeks
Other Name: Tredaptive |
- HDL particles size and number assessed by nuclear magnetic resonance (NMR) and reported as nm and micromol/L [ Time Frame: Two periods of 12 weeks treatment according to crossing over design ]HDL particles were studied by NMR in T2D patients after treatment with fenofibrate or Niacin
- Apolipoprotein A1 (Apo A1), apolipoprotein A2 (Apo A2), paraoxonase (PON) HDL concentration (g/l - mg/l) [ Time Frame: Two periods of 12 weeks treatment according to crossing over design ]Apoprotein and antioxidant enzymes composition of HDL were also measured
- Lecithin-cholesterol acyltransferase (LCAT) and cholesteryl ester transfer protein (CETP) activity (AU - pmol/h*μl) and mass (microg/ml) [ Time Frame: Two periods of 12 weeks treatment according to crossing over design ]LCAT and CETP mass and activities were measured;

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Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 2 diabetic patients
- Age from 30 years to 70 years
- HDL not exceeding 50 mg/dl in men or 60 mg/dl in women
Exclusion Criteria:
- to be a smoker
- To be diagnosed with diabetes less than three months before
- To have triglyceride levels above 400 mg/dl
- Glycated hemoglobin higher than 9%
- Albuminuria above 300 mg/mg creatinine
- Chronic kidney disease (eFGR <30 ml/min/1.73 m2)
- Advanced retinopathy
- Neuropathy
- Cardiovascular disease in the last three months
- Chronic liver insufficiency
- Neoplastic disease or any chronic or incapacitating disease

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): NCT02153879
Spain | |
Hospital Universitari Sant Joan | |
Reus, Tarragona, Spain, 43204 |
Study Director: | Luis Masana, Professor | Institut Investigacio Sanitaria Pere Virgili |
Responsible Party: | LUIS MASANA, MD, Professor, Institut Investigacio Sanitaria Pere Virgili |
ClinicalTrials.gov Identifier: | NCT02153879 |
Other Study ID Numbers: |
IISPV-HUSJR-LOWHDL |
First Posted: | June 3, 2014 Key Record Dates |
Last Update Posted: | June 3, 2014 |
Last Verified: | May 2014 |
HDL Niacin Fenofibrate Diabetes Metabolomics |
Diabetes Mellitus, Type 2 Dyslipidemias Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Lipid Metabolism Disorders Niacin Fenofibrate |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents Vitamin B Complex Vitamins Micronutrients Physiological Effects of Drugs |