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NCT Number: NCT02153879

Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari Sant Joan

Reus, Tarragona, 43204, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fenofibrate

Drug

fenofibrate 145/day for 12 weeks

Other names: Secalip

Niacin plus laropiprant

Drug

Niacin 2 g/day plus Laropiprant for 12 weeks

Other names: Tredaptive

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. 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;

Sponsors and collaborators

Lead sponsor

Institut Investigacio Sanitaria Pere Virgili

Other

Collaborators

  • Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

Registry information

Official study title

Qualitative and Quantitative Characterization of HDL in T2D After Fenofibrate or Niacin Treatment in Spanish Population

Acronym: LOWHDL

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Jun 3, 2014
Registry last updated
Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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