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

Sponsor:

Collaborator:

Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

Information provided by (Responsible Party):

LUIS MASANA, MD, Institut Investigacio Sanitaria Pere Virgili

Study Description

Brief Summary:

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

Detailed Description:

Groups of subjects: a) Diabetic patients with low HDL; b) Non-diabetic patients with low HDL; c) Diabetic patients with normal HDL levels; and d) Non-diabetic patients with normal HDL levels. The studies will be performed after washing out lipid lowering drugs. Intima media thickness (IMT) will be performed in all groups. Main biochemical techniques will be centralised. Isolation and characterisation of HDL subclasses and remnant HDL, as well as a determination and preβ1 HDL will be performed. HDL studies examining HDL proteomic and metabolomic profiles will be performed. Functional studies will determine the effects on the endothelium, inflammation, cholesterol efflux and oxidation according the qualitative changes. These HDL measurements will be repeated in group (a), after they are treated with fibrates or Niacin. HDL metabolism in adipocytes will be extensively studied, and the clinical associations between HDL alterations and plasma AT-derived molecules will be examined.

Study Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Type 2 diabetes

MedlinePlus related topics: Cholesterol Medicines

Drug Information available for: Niacin Niacinamide Fenofibrate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Fenofibrate Fenofibrate 145 mg/day for 12 weeks	Drug: Fenofibrate fenofibrate 145/day for 12 weeks Other Name: Secalip
Experimental: Niacin plus Laropiprant Niacin 2g/day plus Laropiprant for 12 weeks	Drug: Niacin plus laropiprant Niacin 2 g/day plus Laropiprant for 12 weeks Other Name: Tredaptive

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Other Outcome Measures:

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;

Eligibility Criteria

Information from the National Library of Medicine

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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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


Spain
Hospital Universitari Sant Joan
Reus, Tarragona, Spain, 43204

Sponsors and Collaborators

Institut Investigacio Sanitaria Pere Virgili

Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

Investigators


Study Director:	Luis Masana, Professor	Institut Investigacio Sanitaria Pere Virgili

More Information

Additional Information:

Institut Investigacio Sanitaria Pere Virgili- Pere Virgili Health Research institute This link exits the ClinicalTrials.gov site


Responsible Party:	LUIS MASANA, MD, Professor, Institut Investigacio Sanitaria Pere Virgili
ClinicalTrials.gov Identifier:	NCT02153879 History of Changes
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

Keywords provided by LUIS MASANA, MD, Institut Investigacio Sanitaria Pere Virgili:


HDL Niacin Fenofibrate Diabetes Metabolomics

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Lipid Metabolism Disorders Fenofibrate Niacin Niacinamide Nicotinic Acids	Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs

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