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

Completed

• Conditions: Diabetes mellitus type 2.

• Registration Number: NL-OMON24407
• Lead Sponsor: 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

Brief Summary

1. Van de Ree MA, Huisman MV, Princen HM, Meinders AE, Kluft C; DALI-Study Group. Atherosclerosis 2003;166:129-35;<br> 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;<br> 3. Diabetes Atorvastin Lipid Intervention (DALI) Study Group. Diabetes Care. 2001;24:1335-41.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 217

Inclusion Criteria

1. Diabetes mellitus type 2, > 1 year;

2. Male or female;

Exclusion Criteria

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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of atorvastatin 10mg and 80mg on the reduction of triglyceride levels in patients with diabetes mellitus type 2 and hypertriglyceridemia.

Secondary Outcome Measures

Name	Time	Method
The effects on other aspects of diabetic dyslipidemia.