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

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ClinicalTrials.gov Identifier: NCT00953498
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : September 2, 2013
Sponsor:
Information provided by (Responsible Party):
Prof. Bruno Vergès, Centre Hospitalier Universitaire Dijon

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: pioglitazone Drug: rosiglitazone Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Glitazones on the Vasodilatory Effect of HDL Lipoproteins and on Phospholipase A2
Study Start Date : October 2007
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins [ Time Frame: 6 months ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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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): NCT00953498


Locations
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France
Service Endocrinologie-diabétologie, Hôpital du Bocage CHU
Dijon, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
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Principal Investigator: Bruno L Vergès, MD,PhD CHU Dijon
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Bruno Vergès, Professor, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT00953498    
Other Study ID Numbers: AFSSAPS A70516-50
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013
Keywords provided by Prof. Bruno Vergès, Centre Hospitalier Universitaire Dijon:
diabetes
glitazones
HDL
Additional relevant MeSH terms:
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Pioglitazone
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs