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Postprandial effects of dapagliflozin on lipemia and inflammation


- candidate number27801
- NTR NumberNTR6651
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-aug-2017
- Secondary IDsNL57393.101.16 TWOR Maasstad ziekenhuis
- Public TitlePostprandial effects of dapagliflozin on lipemia and inflammation
- Scientific TitlePostprandial Lipemia, Inflammation and Vascular Function in Diabetes modulated by Dapagliflozon
- ACRONYMPLEIADES-dapa
- hypothesisTreatment 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
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Postprandial lipemia
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2017
- planned closingdate31-okt-2018
- Target number of participants20
- Interventions12 weeks treatment with either daily 10 mg dapagliflozin or daily matching placebo.
Before and after treatment oral fat loading test (OFLT).
- Primary outcomePrimary endpoint is effect of dapagliflozin on postprandial leukocyte activation markers (CD11b, CD66b and CD35).
- Secondary outcomeSecondary 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).
- Timepoints0 and 12 weeks
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Benjamin Burggraaf
- CONTACT for SCIENTIFIC QUERIES Benjamin Burggraaf
- Sponsor/Initiator Franciscus Gasthuis
- Funding
(Source(s) of Monetary or Material Support)
Astra Zeneca
- Publications
- Brief summaryFew 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.
- Main changes (audit trail)
- RECORD29-aug-2017 - 1-sep-2017


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