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

Sponsor:	Centre Hospitalier Universitaire Dijon
Information provided by:	Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:	NCT00953498

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

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 ]

Estimated Enrollment:	80
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953498

Contacts

Contact: Bruno L Vergès, MD, PhD	33 3 80 29 34 53	bruno.verges@chu-dijon.fr
Contact: Isabelle Robin, PhD	33 3 80 29 34 53	isabelle.robin@chu-dijon.fr

Locations

France
Service Endocrinologie-diabétologie, Hôpital du Bocage CHU	Recruiting
Dijon, France, 21000
Contact: Bruno L Vergès, MD,PhD 33 3 80 29 34 53 bruno.verges@chu-dijon.fr
Contact: Isabelle Robin, PhD 33 3 80 29 34 53 isabelle.robin@chu-dijon.fr
Principal Investigator: Bruno L Vergès, MD,PhD

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

Principal Investigator:

Bruno L Vergès, MD,PhD

CHU Dijon

More Information

Publications:

Perségol L, Vergès B, Foissac M, Gambert P, Duvillard L. Inability of HDL from type 2 diabetic patients to counteract the inhibitory effect of oxidised LDL on endothelium-dependent vasorelaxation. Diabetologia. 2006 Jun;49(6):1380-6. Epub 2006 Apr 5.

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

Vergès B, Radu L, Baillot-Rudoni S, Brindisi MC, Poussier A, Bouillet B, Petit JM, Duvillard L. Low HDL-cholesterol: a strong predictor of glycemic response to glitazone treatment in patients with type 2 diabetes. Diabetes Res Clin Pract. 2011 Jul;93(1):e44-8. Epub 2011 May 6.

Responsible Party:	Prof. Bruno Vergès, CHU Dijon
ClinicalTrials.gov Identifier:	NCT00953498 History of Changes
Other Study ID Numbers:	AFSSAPS A70516-50
Study First Received:	August 5, 2009
Last Updated:	September 2, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Hospitalier Universitaire Dijon:

diabetes
glitazones
HDL

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Pioglitazone
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012