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…
ID
Bron
Verkorte titel
Aandoening
Type 2 Diabetes Mellitus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary endpoint is effect of dapagliflozin on postprandial leukocyte activation markers (CD11b, CD66b and CD35).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
0 and 12 weeks
Onderzoeksproduct en/of interventie
12 weeks treatment with either daily 10 mg dapagliflozin or daily matching placebo.
Before and after treatment oral fat loading test (OFLT).
Publiek
Benjamin Burggraaf
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
b.burggraaf@franciscus.nl
Wetenschappelijk
Benjamin Burggraaf
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
b.burggraaf@franciscus.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6335 |
| NTR-old | NTR6651 |
| CCMO | NL57393.101.16 |
| OMON | NL-OMON46285 |