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Dapagliflozin on cholesterol metabolism in DM2: dissecting its effect on dyslipidemia by using stable isotope based cholesterol and glucose fluxes


- candidate number25217
- NTR NumberNTR6066
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-aug-2016
- Secondary IDs2016/16 
- Public TitleDapagliflozin on cholesterol metabolism in DM2: dissecting its effect on dyslipidemia by using stable isotope based cholesterol and glucose fluxes
- Scientific TitleDapagliflozin on cholesterol metabolism in DM2: dissecting its effect on dyslipidemia by using stable isotope based cholesterol and glucose fluxes
- ACRONYMDICE
- hypothesisType 2 diabetes is associated with an increased cardiovascular risk. Besides metformin, a new treatment strategy is oral SGLT2 inhibition (dapagliflozon), Although two recently published, first-in-class cardiovascular outcome trials (EmparegMPA-REG OUTCOME and TECOS trial) have has suggested a beneficial effect on all cause cardiovascular mortalitity upon SGLT2 inhibition, a known (class) side effect in worsening of dyslipidemia in all DM2 patients. We thus aim to dissect the effect of SGLT2 inhibition (Dapagliflozin 10mg once daily for 5 weeks) on glucose and lipid fluxes in uncomplicated DM2 subjects.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Dyslipemia
- Inclusion criteria-Male or postmenopauzal female patients ;
-Type 2 diabetes mellitus(HbA1C ≥6.5% - <8.5%)
-At least 12 weeks of stable dose metformin treatment, FPG<13.2 mmol/l -LDL cholesterol >2.5 mmol/l
-Willing to switch used statin to rosuvastatin 10mg once daily
-18-75 years of age
-Ability to provide informed consent
- Exclusion criteriaHistory of cardiovascular event
-Smoking
-exogenous insulin use
-Creatinin clearance < 60ml/min
-Alcohol abuse (>4 units/day)
-AST or ALT elevation (>2.5x upper limit) -Contraindication to MR scanning (i.e. pacemaker, metallic foreign body, claustrophobia)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2016
- planned closingdate1-sep-2018
- Target number of participants12
- Interventionsdapagliflozin 10mg once daily
- Primary outcomeOur primary endpoint is effect of 5 weeks SLGT2 inhibition on LDL cholesterol synthesis in patients with DM2.
- Secondary outcomeSecondary endpoints are effect of SGLT2 inhibition on triglyceride and cholesterol fluxes as well as (hepatic and peripheral) insulin sensitivity and energy expenditure. Finally, effect of SGLT2 inhibition on dietary intake, liver fat content (MRI liver) and fecal microbiome will be studied at these timepoints.
- Timepoints0 and 5 weeks
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Astra Zeneca
- Publications
- Brief summaryType 2 diabetes is associated with an increased cardiovascular risk. Although two the recently published trials have suggested a beneficial effect on all cause cardiovascular mortalitity upon SGLT2 inhibition, a known (class) side effect in worsening of dyslipidemia in all DM2 patients. We thus aim to dissect the effect of SGLT2 inhibition (Dapagliflozin 10mg once daily for 5 weeks) on glucose and lipid fluxes in uncomplicated DM2 subjects.
- Main changes (audit trail)
- RECORD29-aug-2016 - 25-nov-2016


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