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临床试验/NCT00815399
NCT00815399已完成4 期

Effect of Pioglitazone Compared With Metformin on Endothelial Microparticles in Type 2 Diabetes. A Randomized Trial

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
150
试验地点
1
主要终点
Circulating Endothelial microparticles

研究概览

简要总结

Type 2 diabetes is an epidemic. Its long-term consequences translate into enormous human suffering and economic costs; however, much of the morbidity associated with long-term microvascular and neuropathic complications can be substantially reduced by interventions that achieve glucose levels close to the nondiabetic range. However, none of the recent intervention studies has demonstrated a benefit of intensive glycemic control on their primary CVD outcomes.

The investigators report the findings of a long-term randomized and comparator-controlled clinical trial conducted in patients with newly-diagnosed type 2 diabetes. The investigators compared the effect of pioglitazone with that of metformin on circulating endothelial cell-derived submicroscopic membranous vesicles, termed microparticles: because of their putative role in inflammatory processes and their ability to directly affect endothelial functions, they are gaining increasing popularity as a surrogate marker of cardiovascular outlook. Metformin was chosen as a comparator because the American Diabetes Association recommendations suggest to start therapy in newly-diagnosed type 2 diabetic subjects combining a drug (metformin) with lifestyle changes. Moreover, the mechanism of action of pioglitazone is distinct from that of metformin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 30-75 years, with newly-diagnosed type 2 diabetes (according to the ADA criteria) and never treated with antihyperglycemic drugs, were selected for the study. Inclusion criteria also included a body mass index (BMI) >25 kg/m2, and HbA1c level <10%.

排除标准

  • Pregnancy or breast-feeding
  • Any investigational drug within the previous 3 months
  • Use of agents affecting glycemic control (systemic glucocorticoids, and weight-loss drugs)
  • Presence of any clinically relevant somatic or mental diseases that anticipated poor adherence to diet regimens
  • To minimize the likelihood of including subjects with late-onset type 1 diabetes, candidates with a positive test for anti-GAD antibody or with fasting plasma C-peptide less than 0.76 ng/L (<0.25 pmol/L) were excluded
  • Also excluded were patients with abnormal laboratory tests, including liver enzymes (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) greater than 3 times the upper limit of normal, and serum creatinine greater than 123.8 μmol/L (1.4 mg/dL).

研究组 & 干预措施

1

Experimental

干预措施: Pioglitazone (Drug)

2

Active Comparator

干预措施: Metformin (Drug)

结局指标

主要结局

Circulating Endothelial microparticles

时间窗: six months

次要结局

  • Glucose profile, lipid profile, hemoglobin A1c, carotid intima-media thickness(six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dario Giugliano

Prof of Endocrinology and Metabolism

University of Campania "Luigi Vanvitelli"

研究点 (1)

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