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| Sponsor: | Centre Hospitalier Universitaire Dijon |
|---|---|
| Information provided by: | Centre Hospitalier Universitaire Dijon |
| ClinicalTrials.gov Identifier: | NCT00953498 |
Purpose
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:
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: pioglitazone Drug: rosiglitazone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | Influence of Glitazones on the Vasodilatory Effect of HDL Lipoproteins and on Phospholipase A2 |
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
pioglitazone: Active Comparator
treatment with pioglitazone (dose from 30 mg:day to 45 mg/day)
|
Drug: pioglitazone
After randomization, patients will be treated by pioglitazone or rosiglitazone
|
|
rosiglitazone: Active Comparator
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
|
Drug: rosiglitazone
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bruno L Vergès, MD, PhD | 33 3 80 29 34 53 | bruno.verges@chu-dijon.fr |
| Contact: Isabelle Robin, PhD | 33 3 80 29 34 53 | isabelle.robin@chu-dijon.fr |
| France | |
| Service Endocrinologie-diabétologie, Hôpital du Bocage CHU | Recruiting |
| Dijon, France, 21000 | |
| Contact: Bruno L Vergès, MD,PhD 33 3 80 29 34 53 bruno.verges@chu-dijon.fr | |
| Contact: Isabelle Robin, PhD 33 3 80 29 34 53 isabelle.robin@chu-dijon.fr | |
| Principal Investigator: Bruno L Vergès, MD,PhD | |
| Principal Investigator: | Bruno L Vergès, MD,PhD | CHU Dijon |
More Information
| Responsible Party: | CHU Dijon ( Prof. Bruno Vergès ) |
| Study ID Numbers: | AFSSAPS A70516-50 |
| Study First Received: | August 5, 2009 |
| Last Updated: | September 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00953498 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
diabetes glitazones HDL |
|
Hypoglycemic Agents Metabolic Diseases Pioglitazone Physiological Effects of Drugs Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Rosiglitazone Pharmacologic Actions |