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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Dijon, 프랑스, 21000
- Service Endocrinologie-diabétologie, Hôpital du Bocage CHU
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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
다른 이름들:
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활성 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Action of glitazone on the endothelium-dependent vasodilatory effects of HDL lipoproteins
기간: 6 months
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6 months
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2차 결과 측정
결과 측정 |
기간 |
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Effect of glitazone therapy on Phospholipase A2 level
기간: 6 months
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6 months
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Analyze the glycemic response to glitazones according to baseline clinical and biological characteristics
기간: 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
기간: 6 months
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Bruno L Vergès, MD,PhD, CHU Dijon
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
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처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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