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

University Hospital Center (CHU) Dijon Bourgogne

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: rosiglitazone; Drug: pioglitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT00953498

AFSSAPS A70516-50

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

pioglitazone

Active Comparator group

Description:

treatment with pioglitazone (dose from 30 mg:day to 45 mg/day)

Treatment:

Drug: pioglitazone

rosiglitazone

Active Comparator group

Description:

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

Treatment:

Drug: rosiglitazone