Influence of Glitazones on the Vasodilatory Effect of High-density Lipoprotein (HDL) Lipoproteins

August 30, 2013 updated by: Prof. Bruno Vergès, Centre Hospitalier Universitaire Dijon

Influence of Glitazones on the Vasodilatory Effect of HDL Lipoproteins and on Phospholipase A2

HDL from patients with type 2 diabetes show a significant reduction of their endothelium-dependent vasodilatory effect.

The primary objective of the study is to analyze whether treatment with glitazones (pioglitazone and rosiglitazone)may improve the endothelium-dependent vasodilatory effect of HDL lipoproteins in patients with type 2 diabetes.

The secondary objectives are:

  • to analyze the effect of glitazone treatment on phospholipase A2
  • to look for possible differences between the effects of pioglitazone and those of rosiglitazone
  • to analyze the glycemic response to glitazone therapy according to clinical and biological baseline characteristics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be performed as follows:

At baseline, before initiating glitazone treatment, clinical data will be recorded and blood samples will be obtained for biological measurements (blood glucose, HbA1c, total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, liver enzymes), phospholipase A2 measurement and the study of the vasodilatory effect of HDL particles.For this purpose, we will study,using rabbit aorta rings,the ability of HDL to suppress the inhibition of vasodilation that is induced by oxidised LDL.

For all the patients included into the study, a treatment by pioglitazone (at an initial dose of 30 mg/day) or rosiglitazone (at an initial dose of 4 mg/day) will be given by randomization.

A visit will be performed at week 12, in order to titrate the glitazone dose (up to 45 mg/day for pioglitazone, up to 8 mg/day for rosiglitazone)according to HbA1c level and values of self-monitoring blood glucose.

At week 24, the last visit will take place. During this visit, clinical data will be recorded and blood samples will be obtained for biological measurements (blood glucose, HbA1c, total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, liver enzymes), phospholipase A2 measurement and the study of the vasodilatory effect of HDL particles.

Study Type

Interventional

Enrollment (Actual)

40

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

  • France
      • Dijon, France, 21000
        • Service Endocrinologie-diabétologie, Hôpital du Bocage CHU

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with type 2 diabetes treated by oral antidiabetic agents (except glitazones) and/or insulin
  • age> 18 years
  • HbA1c > 6.5%

Exclusion Criteria:

  • renal failure
  • heart failure
  • primary hyperlipidemia
  • pregnancy
  • treatment that may modify lipid metabolism (glucocorticoids, oestrogens, retinoids, HIV antiviral drugs)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pioglitazone
treatment with pioglitazone (dose from 30 mg:day to 45 mg/day)
Drug: pioglitazone
After randomization, patients will be treated by pioglitazone or rosiglitazone
Other Names:
  • pioglitazone: ACTOS
  • rosiglitazone: AVANDIA
Active Comparator: rosiglitazone
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
Drug: rosiglitazone
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
Other Names:
  • pioglitazone: ACTOS
  • rosiglitazone: AVANDIA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of glitazone therapy on Phospholipase A2 level
Time Frame: 6 months
6 months
Analyze the glycemic response to glitazones according to baseline clinical and biological characteristics
Time Frame: 6 months
6 months
Look for possible differences between pioglitazone and rosiglitazone for their effects on HDL lipoproteins and phospholipase A2
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

Investigators

  • Principal Investigator: Bruno L Vergès, MD,PhD, CHU Dijon

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.

General Publications

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

October 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

September 2, 2013

Last Update Submitted That Met QC Criteria

August 30, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFSSAPS A70516-50

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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