Influence of insulin Levemir on endothelial function in type 2 diabetes mellitus. A prospective case-control study. - Levemir on endothelial functio
- Conditions
- Patients with known history of type 2 Diabetes Mellitus longer than 6 months, who were treated by diet in combination with oral antidiabetic drugs (OADs) are to be included in the study.
- Registration Number
- EUCTR2006-005175-18-AT
- Lead Sponsor
- Dpt. of Internal Medicine, Medical University of Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 75
All patients are recruited from the diabetes outpatient department of the department of Internal Medicine, Medical University Innsbruck. Patients’ inclusion criteria are the gender (female), the subject’s age (35 to 55 years), history of type 2 DM over 6 months and level of glycosylated hemoglobin (HbA1c) >7% despite pre-existing treatment with diet and OADs.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
To reduce the confounding effects of other cardiovascular risk factors often associated with type 2 DM, patients with inadequately controlled hypertension (blood pressure >135/85 mmHg), with hyperlipidemias other than the high triglyceride-low high-density lipoprotein (HDL) cholesterol diabetic dislipidemia, and with a history of cardiovascular disease and smoking are excluded from the study. Medical treatment of hypertension and dyslipidemia remains unchanged 6 weeks before recruitment and is continued during the study protocol. Acute infectious and inflammatory diseases, as well as hepatic, renal and cardiac failure are excluded by taking a careful history and performing physical and laboratory examinations. Also, breastfeeding and pregnant women are excluded from the study protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method