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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43515

Enrollment

Registered

2016-04-07

Start date

2016-09-06

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

cholesterol diabetes mellitus

Interventions

dapagliflozin 10mg once daily for 5 weeks and rosuvastatin 10mg 1dd during 9 weeks

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Male or postmenopauzal female patients with type 2 diabetes mellitus(HbA1C *6.5% - 2.5 mmol/l -Willing to switch used statin to rosuvastatin 10mg once daily for 9 weeks -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
effect of 5 weeks dapagliflozin 10mg on top of rosuvastatin treatment on LDL de novo lipogenesis compared to rosuvastatin 10mg therapy only or no medication	—

Secondary

Measure	Time frame
Effect of 5 weeks dapagliflozin 10mg on: -Change in VLDL secretion and clearance (as determined by 2H3 Leucine enrichment) and relation to plasma CETP, PLTP and HDL subfractions - (dietary) Triglyceride fluxes (as determined by 1,2,3,4-13C16 * palmitate to measure FFA remnant uptake). - hepatic and peripheral insulin sensitivity (2 step Hyperinsulinemic normoglycemic clamp with 2H2enriched glucose:) and energy expenditure including carbohydrate oxidation and fatty acid oxidation rates in breathing air - liver fat content (MRI liver) -change in fecal microbiome composition -cholesterol and bile salt excretion	—

Measure

Time frame

Effect of 5 weeks dapagliflozin 10mg on: -Change in VLDL secretion and clearance (as determined by 2H3 Leucine enrichment) and relation to plasma CETP, PLTP and HDL subfractions - (dietary) Triglyceride fluxes (as determined by 1,2,3,4-13C16 * palmitate to measure FFA remnant uptake). - hepatic and peripheral insulin sensitivity (2 step Hyperinsulinemic normoglycemic clamp with 2H2enriched glucose:) and energy expenditure including carbohydrate oxidation and fatty acid oxidation rates in breathing air - liver fat content (MRI liver) -change in fecal microbiome composition -cholesterol and bile salt excretion

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)