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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pioglitazone | Active Comparator | treatment with pioglitazone (dose from 30 mg:day to 45 mg/day) |
|
| rosiglitazone | Active Comparator | treatment with rosiglitazone at a dose between 4mg and 8 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pioglitazone | Drug | After randomization, patients will be treated by pioglitazone or rosiglitazone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of glitazone therapy on Phospholipase A2 level | 6 months | |
| Analyze the glycemic response to glitazones according to baseline clinical and biological characteristics | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno L Vergès, MD,PhD | CHU Dijon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service Endocrinologie-diabétologie, Hôpital du Bocage CHU | Dijon | 21000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16596357 | Background | Persegol L, Verges 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. doi: 10.1007/s00125-006-0244-1. Epub 2006 Apr 5. | |
| 21529978 | Derived | Verges 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. doi: 10.1016/j.diabres.2011.04.005. Epub 2011 May 6. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| rosiglitazone | Drug | treatment with rosiglitazone at a dose between 4mg and 8 mg/day |
|
|
| Look for possible differences between pioglitazone and rosiglitazone for their effects on HDL lipoproteins and phospholipase A2 |
| 6 months |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |