Influence of Glitazones on the Vasodilatory Effect of High-density Lipoprotein (HDL) Lipoproteins
Influence of Glitazones on the Vasodilatory Effect of HDL Lipoproteins and on Phospholipase A2
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Dijon, Frankrig, 21000
- Service Endocrinologie-diabétologie, Hôpital du Bocage CHU
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: pioglitazone
treatment with pioglitazone (dose from 30 mg:day to 45 mg/day)
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After randomization, patients will be treated by pioglitazone or rosiglitazone
Andre navne:
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Aktiv komparator: rosiglitazone
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
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treatment with rosiglitazone at a dose between 4mg and 8 mg/day
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins
Tidsramme: 6 months
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6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Effect of glitazone therapy on Phospholipase A2 level
Tidsramme: 6 months
|
6 months
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Analyze the glycemic response to glitazones according to baseline clinical and biological characteristics
Tidsramme: 6 months
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6 months
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Look for possible differences between pioglitazone and rosiglitazone for their effects on HDL lipoproteins and phospholipase A2
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Bruno L Vergès, MD,PhD, CHU Dijon
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AFSSAPS A70516-50
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