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NCT Number: NCT00953498

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service Endocrinologie-diabétologie, Hôpital du Bocage CHU

Dijon, 21000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

pioglitazone

Drug

After randomization, patients will be treated by pioglitazone or rosiglitazone

Other names: pioglitazone: ACTOS, rosiglitazone: AVANDIA

rosiglitazone

Drug

treatment with rosiglitazone at a dose between 4mg and 8 mg/day

Other names: pioglitazone: ACTOS, rosiglitazone: AVANDIA

Primary outcomes

  1. Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 6, 2009
Registry last updated
Sep 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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