Type 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…
ID
Bron
Verkorte titel
Aandoening
diabetes type 2
dyslipidemia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Our primary endpoint is effect of 5 weeks SLGT2 inhibition on LDL cholesterol synthesis in patients with DM2.
Achtergrond van het onderzoek
Type 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.
Doel van het onderzoek
Type 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.
Onderzoeksopzet
0 and 5 weeks
Onderzoeksproduct en/of interventie
dapagliflozin 10mg once daily
Publiek
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
Wetenschappelijk
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
History 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)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5783 |
| NTR-old | NTR6066 |
| Ander register | - : 2016/16 |