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Influence of Glitazones on the Vasodilatory Effect of High-density Lipoprotein (HDL) Lipoproteins
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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:
- 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.
| Condition | Intervention | Phase |
|---|---|---|
| Type 2 Diabetes | Drug: pioglitazone Drug: rosiglitazone | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Influence of Glitazones on the Vasodilatory Effect of HDL Lipoproteins and on Phospholipase A2 |
- 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 ]
| Enrollment: | 40 |
| Study Start Date: | October 2007 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: pioglitazone
treatment with pioglitazone (dose from 30 mg:day to 45 mg/day)
|
Drug: pioglitazone
After randomization, patients will be treated by pioglitazone or rosiglitazone
Other Names:
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Active Comparator: rosiglitazone
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
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Drug: rosiglitazone
treatment with rosiglitazone at a dose between 4mg and 8 mg/day
Other Names:
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Detailed Description:
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00953498
| France | |
| Service Endocrinologie-diabétologie, Hôpital du Bocage CHU | |
| Dijon, France, 21000 | |
| Principal Investigator: | Bruno L Vergès, MD,PhD | CHU Dijon |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Bruno Vergès, Professor, Centre Hospitalier Universitaire Dijon |
| ClinicalTrials.gov Identifier: | NCT00953498 History of Changes |
| Other Study ID Numbers: |
AFSSAPS A70516-50 |
| Study First Received: | August 5, 2009 |
| Last Updated: | August 30, 2013 |
Keywords provided by Prof. Bruno Vergès, Centre Hospitalier Universitaire Dijon:
|
diabetes glitazones HDL |
Additional relevant MeSH terms:
|
Pioglitazone Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017