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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28993

Enrollment

Registered

2016-08-29

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes type 2 dyslipidemia

Interventions

dapagliflozin 10mg once daily

Eligibility

Inclusion criteria

Inclusion criteria: -Male or postmenopauzal female patients ; -Type 2 diabetes mellitus(HbA1C ≥6.5% - 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

Exclusion criteria: History of cardiovascular event -Smoking -exogenous insulin use -Creatinin clearance 4 units/day) -AST or ALT elevation (>2.5x upper limit) -Contraindication to MR scanning (i.e. pacemaker, metallic foreign body, claustrophobia)

Design outcomes

Primary

Measure	Time frame
Our primary endpoint is effect of 5 weeks SLGT2 inhibition on LDL cholesterol synthesis in patients with DM2.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactM. Nieuwdorp

AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2

m.nieuwdorp@amc.uva.nl+31 (0)20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)