Postprandial Lipemia, Inflammation, and Vascular Function in Diabetes modulated by dapagliflozi

Phase 4

Completed

Conditions: Atherosclerose
postmeal fat influence
10018424
10013317
10003216

Registration Number: NL-OMON46285

Lead Sponsor: Sint Franciscus Gasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

- Age of 18 years of older
- Male sex
- Diabetes mellitus type II on intensive insulin treatment (three times short acting and once daily long acting)(unchanged for >10 weeks prior to inclusion
- Stable glucose regulation last 6 months (HbA1c >6.5% - <9%)
- Provision of informed consent prior to any study procedure

Exclusion Criteria

- Current smoking
- Impaired renal function (MDRD <60 ml/min/1.73m2)
- Recent use of SGLT2 inhibitior (past 6 months)
- Recent cardiovascular event (past 6 months) (myocardial infarction, coronary artery bypass grafting, stroke)
- Severe hyperglycemic events in the past 6 months (hyperglycemie > 20mmol/l requiring hospital admission)
- Provision of informed consent prior to any study procedure
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrollment in the present study
- Participation in another clinical study with an investigational product during the last 6 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study endpoint will be postprandial leukocyte activation, measured by<br /><br>CD35, CD11b and CD66b.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints will be postprandial lipemia (plasma apoB, HDL-c, LDL-c,<br /><br>total cholesterol and triglycerides), oxidative stress (lipoperoxidase) and<br /><br>vascular function (arterial pulse wave velocity and arterial pulse wave<br /><br>analysis). Furthermore, we will measure fasting and postprandial levels of free<br /><br>fatty acids and b-hydroxybutyrate, to explore the molecular mechanisms involved<br /><br>in SGLT2 inhibition related to lipid metabolism. </p><br>