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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Bruno Vergès, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT00953498
First received: August 5, 2009
Last updated: August 30, 2013
Last verified: August 2013

August 5, 2009
August 30, 2013
October 2007
March 2012   (final data collection date for primary outcome measure)
Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00953498 on ClinicalTrials.gov Archive Site
  • Effect of glitazone therapy on Phospholipase A2 level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Analyze the glycemic response to glitazones according to baseline clinical and biological characteristics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Look for possible differences between pioglitazone and rosiglitazone for their effects on HDL lipoproteins and phospholipase A2 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influence of Glitazones on the Vasodilatory Effect of High-density Lipoprotein (HDL) Lipoproteins
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: pioglitazone
    After randomization, patients will be treated by pioglitazone or rosiglitazone
    Other Names:
    • pioglitazone: ACTOS
    • rosiglitazone: AVANDIA
  • Drug: rosiglitazone
    treatment with rosiglitazone at a dose between 4mg and 8 mg/day
    Other Names:
    • pioglitazone: ACTOS
    • rosiglitazone: AVANDIA
  • Active Comparator: pioglitazone
    treatment with pioglitazone (dose from 30 mg:day to 45 mg/day)
    Intervention: Drug: pioglitazone
  • Active Comparator: rosiglitazone
    treatment with rosiglitazone at a dose between 4mg and 8 mg/day
    Intervention: Drug: rosiglitazone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2012
March 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00953498
AFSSAPS A70516-50
Yes
Prof. Bruno Vergès, Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire Dijon
Not Provided
Principal Investigator: Bruno L Vergès, MD,PhD CHU Dijon
Centre Hospitalier Universitaire Dijon
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP