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
  Purpose

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 Intervention Phase
Type 2 Diabetes
Drug: pioglitazone
Drug: rosiglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Glitazones on the Vasodilatory Effect of HDL Lipoproteins and on Phospholipase A2

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: October 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00953498

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Bruno Vergès, Professor, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT00953498     History of Changes
Other Study ID Numbers: AFSSAPS A70516-50
Study First Received: August 5, 2009
Last Updated: August 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire Dijon:
diabetes
glitazones
HDL

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014