Atherosclerose postmeal fat influence
Conditions
Interventions
Two oral fat load tests (OFLTs) will be performed. After the first OFLT,
volunteers will be randomly assigned to receive 12 weeks of either
dapagliflozin daily or a placebo. Twelve weeks later the O
Sponsors
Sint Franciscus Gasthuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age of 18 years of older - Male sex - Diabetes mellitus type II on intensive insulin treatment (three times short acting and once daily long acting)(unchanged for >10 weeks prior to inclusion - Stable glucose regulation last 6 months (HbA1c >6.5% -
Exclusion criteria
Exclusion criteria: - Current smoking - Impaired renal function (MDRD 20mmol/l requiring hospital admission) - Provision of informed consent prior to any study procedure - Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) - Previous enrollment in the present study - Participation in another clinical study with an investigational product during the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study endpoint will be postprandial leukocyte activation, measured by CD35, CD11b and CD66b. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be postprandial lipemia (plasma apoB, HDL-c, LDL-c, total cholesterol and triglycerides), oxidative stress (lipoperoxidase) and vascular function (arterial pulse wave velocity and arterial pulse wave analysis). Furthermore, we will measure fasting and postprandial levels of free fatty acids and b-hydroxybutyrate, to explore the molecular mechanisms involved in SGLT2 inhibition related to lipid metabolism. | — |
Countries
Netherlands
Outcome results
None listed