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ID
Source
Brief title
Health condition
diabetes type 2
dyslipidemia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary endpoint is effect of 5 weeks SLGT2 inhibition on LDL cholesterol synthesis in patients with DM2.
Secondary outcome
Secondary 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.
Background summary
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.
Study objective
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.
Study design
0 and 5 weeks
Intervention
dapagliflozin 10mg once daily
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
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 criteria
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)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL5783 |
| NTR-old | NTR6066 |
| Other | - : 2016/16 |