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

June 2, 2014 updated by: LUIS MASANA, MD, Institut Investigacio Sanitaria Pere Virgili

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fenofibrate
Fenofibrate 145 mg/day for 12 weeks
Drug: Fenofibrate
fenofibrate 145/day for 12 weeks
Other Names:
  • 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 Names:
  • Tredaptive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two periods of 12 weeks treatment according to crossing over design

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two periods of 12 weeks treatment according to crossing over design

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
Two periods of 12 weeks treatment according to crossing over design

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Investigacio Sanitaria Pere Virgili

Collaborators

Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

June 2, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2014

Last Update Submitted That Met QC Criteria

June 2, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IISPV-HUSJR-LOWHDL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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