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临床试验/NL-OMON24407
NL-OMON24407已完成不适用

The DALI study: a double-blind randomized placebo-controlled trial in patients with diabetes mellitus type 2 and hypertriglyceridemia.

Erasmus Medical Center Rotterdam, Department of Internal Medicine and Departments of Biochemistry and Clinical Chemistry; Gaubius Laboratory TNO-PG, Leiden; Leiden University Medical Center; University Medical Center Utrecht, Julius Center for General Practice and Patient Oriented Research; University Medical Center Utrecht, Division of Internal Medicine0 个研究点目标入组 217 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
217

研究概览

简要总结

  1. Van de Ree MA, Huisman MV, Princen HM, Meinders AE, Kluft C; DALI-Study Group. Atherosclerosis 2003;166:129-35;
    2. Van Venrooij FV, van de Ree MA, Bots ML, Stolk RP, Huisman MV, Banga JD; DALI Study Group. Diabetes Care Jul;25:1211-6;
    3. Diabetes Atorvastin Lipid Intervention (DALI) Study Group. Diabetes Care. 2001;24:1335-41.

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Diabetes mellitus type 2, > 1 year;
  • 2. Male or female;

排除标准

  • 1. History of myocardial infarction, PTCA, CABG, clinical symptoms of manifest coronary artery disease (> grade II of the Canadian Cardiovascular Society), severe or unstable angina pectoris (> grade II), clinically manifest heart failure (> grade II NYHA) and severe cardiac arrhytmias;
  • 2. Premenopausal women, patients with acute liver disease or hepatic dysfunction, impaired renal function (plasma creatinine > 150 mmol/l), a history of partial ileal bypass surgery, any surgical procedure or any systemic inflammatory disease within the last three months before randomization, malignancies, vasculitis, rheumatic arthritis, idiopathic lung fibrosis, ulcerative colitis or Crohn’s disease;

研究者

发起方
Erasmus Medical Center Rotterdam, Department of Internal Medicine and Departments of Biochemistry and Clinical Chemistry; Gaubius Laboratory TNO-PG, Leiden; Leiden University Medical Center; University Medical Center Utrecht, Julius Center for General Practice and Patient Oriented Research; University Medical Center Utrecht, Division of Internal Medicine

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