A Phase 4 interventional study of pioglitazone and rosiglitazone in Type 2 Diabetes, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-02.
Sponsored by Centre Hospitalier Universitaire Dijon · Phase 4, Interventional, and Treatment
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 40 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
treatment with pioglitazone (dose from 30 mg:day to 45 mg/day)
Drug: pioglitazone
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
Drug: rosiglitazone
After randomization, patients will be treated by pioglitazone or rosiglitazone
Also known as: pioglitazone: ACTOS, rosiglitazone: AVANDIA
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
Also known as: pioglitazone: ACTOS, rosiglitazone: AVANDIA
Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins
Time frame: 6 months
Effect of glitazone therapy on Phospholipase A2 level
Time frame: 6 months
Analyze the glycemic response to glitazones according to baseline clinical and biological characteristics
Time frame: 6 months
Look for possible differences between pioglitazone and rosiglitazone for their effects on HDL lipoproteins and phospholipase A2
Time frame: 6 months
The record gives a start of Oct 2007, a primary completion of Mar 2012 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Pioglitazone · Rosiglitazone
Centre Hospitalier Universitaire Dijon →