No registrations found.
ID
Source
Brief title
Health condition
Diabetes mellitus type 2.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of atorvastatin 10mg and 80mg on the reduction of triglyceride levels in patients with diabetes mellitus type 2 and hypertriglyceridemia.
Secondary outcome
The effects on other aspects of diabetic dyslipidemia.
Background summary
Objective:
In patients with diabetes mellitus type 2 intensive glucose regulation, while effective for microangiopathy, has only limited effects on the occurrence of cardiovascular disease. Diabetic patients show a characteristic dyslipidemia (high triglycerides, low HDL-cholesterol). Aggressive lowering of triglycerides might be an effective method to reduce the cardiovascular risk in these patients;
Research design and methods:
A double-blind placebo-controlled randomized study to assess the effect of 30 weeks atorvastatin 10mg and 80mg on plasma triglyceride levels in 217 patients with diabetes mellitus type 2 and fasting triglycerides between 1.5 and 6.0 mmol/L.
Study objective
Higher doses of statins will result in additional improvement of the diabetic lipid profile.
Study design
N/A
Intervention
Patients who met the in- and exclusion criteria started with a placebo run-in period. If the lipid levels were still within the inclusion range after two weeks, patients were randomized to treatment with atorvastatin 10mg, 80mg, or placebo, administered once daily in the morning. Patients randomized to atorvastatin 80mg started with 40mg for four weeks after which the dose was increased to 80mg. The total treatment period was 30 weeks.
Department of Thrombosis and Haemostasis<br>
Room C4-68<br>
P.O Box 9600
M.V. Huisman
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262085
m.v.huisman@lumc.nl
Department of Thrombosis and Haemostasis<br>
Room C4-68<br>
P.O Box 9600
M.V. Huisman
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262085
m.v.huisman@lumc.nl
Inclusion criteria
1. Diabetes mellitus type 2, > 1 year;
2. Male or female;
3. HbA1c 10% or lower;
4. Fasting total cholesterol level between 4.0 and 8.0 mmol/L;
5. Fasting triglycerides level between 1.5 and 6.0 mmol/L.
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;
3. Patients who consumed more than 4 alcoholic drinks per day or who used systemic steroids, androgens, cyclosporin, other immunosuppressive drugs, erythromycin or mibefradil.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL266 |
| NTR-old | NTR304 |
| Other | : N/A |
| ISRCTN | ISRCTN72259862 |
Summary results
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.