Influence of Glitazones on the Vasodilatory Effect of High-density Lipoprotein (HDL) Lipoproteins
NCT ID: NCT00953498
Last Updated: 2013-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2007-10-31
2012-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
pioglitazone
treatment with pioglitazone (dose from 30 mg:day to 45 mg/day)
pioglitazone
After randomization, patients will be treated by pioglitazone or rosiglitazone
rosiglitazone
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
rosiglitazone
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
pioglitazone
After randomization, patients will be treated by pioglitazone or rosiglitazone
rosiglitazone
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age\> 18 years
* HbA1c \> 6.5%
Exclusion Criteria
* heart failure
* primary hyperlipidemia
* pregnancy
* treatment that may modify lipid metabolism (glucocorticoids, oestrogens, retinoids, HIV antiviral drugs)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Bruno Vergès
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bruno L Vergès, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
CHU Dijon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Service Endocrinologie-diabétologie, Hôpital du Bocage CHU
Dijon, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AFSSAPS A70516-50
Identifier Type: -
Identifier Source: org_study_id