No registrations found.
ID
Source
Brief title
Health condition
Type 2 Diabetes Mellitus
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is effect of dapagliflozin on postprandial leukocyte activation markers (CD11b, CD66b and CD35).
Secondary outcome
Secondary endponts are the effect of 12 weeks of treatment with dapagliflozin on postprandial lipemia (apoB48, triglycerides, free fatty acids and b-hydroxybutyrate), oxidative stress (myeloperoxidase) and vascular function (arterial pulse wave velocity and arterial pulse wave analysis).
Background summary
Few studies have proven to be efficient in reducing cardiovascular risk in diabetes. Recently, a SGLT2-inhibitor (empagliflozin) showed a significant reduction in cardiovascular mortality without a clear mechanism for this reduction. We aim to explore the inflammatory changes of dapagliflozin compared with placebo on postprandial lipemia and postprandial leukocyte activation, oxidative stress and endothelial function in men with type 2 diabetes mellitus using insulin.
Study objective
Treatment with dapagliflozin will reduce postprandial hyperlipidemia and thus reduce postprandial leukocyte activation, diminish the generation of postprandial oxidative stress and improve postprandial vascular dysfunction in men with type 2 diabetes mellitus
Study design
0 and 12 weeks
Intervention
12 weeks treatment with either daily 10 mg dapagliflozin or daily matching placebo.
Before and after treatment oral fat loading test (OFLT).
Benjamin Burggraaf
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
b.burggraaf@franciscus.nl
Benjamin Burggraaf
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
b.burggraaf@franciscus.nl
Inclusion criteria
• Age of 18 years of older;
• Male
• Diabetes mellitus type 2 on intensive insulin treatment (three times short acting and once daily long acting) (unchanged for > 10 weeks prior to consent)
• Stable glucose regulation last 6 months (HbA1c > 6.5% - < 9.0%)
• Provision of informed consent prior to any study procedure
Exclusion criteria
• Current smoking
• Impaired renal function (MDRD <60 ml/min/1.73 m2)
• Recent use of SGLT-2 inhibitor (past 6 months)
• Recent cardiovascular event (past 6 months) (myocardial infarction, coronary artery bypass grafting, stroke)
• Severe hyperglycemic events in the past 6 months (hyperglycemia >20 mmol/l requiring hospital admittance)
• 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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6335 |
| NTR-old | NTR6651 |
| CCMO | NL57393.101.16 |
| OMON | NL-OMON46285 |