Adult-onset diabetes Type 2 Diabetes Mellitus
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Group 2: T2DM patients without impaired kidney function * Male between 40 and 75 years old * Caucasian * Average daily sodium intake of 150 mmol/day * Known with Diabetes Mellitus - type 2, according to the ADA criteria * Without macroalbuminuria defined as albumin-to-creatinine ratio >300 mg/mmol in a morning urine sample. * Stable renal function (creatinine clearance > 60 ml/min and
Exclusion criteria
Exclusion criteria: * An office blood pressure >160/90 mmHg * A major illness in the past 3 months or any significant chronic medical illness that the Investigator would deem unfavourable for enrolment, including chronic inflammatory diseases * Current use of the following medication: thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, oral glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants, diuretics and monoamine oxidase inhibitors, short-acting insulin, 21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits * Difficulty in donating blood or limited accessibility of a vein in left and right arm * Subject has donated blood in last 3 months * Use of tobacco products * Any other issue that, in the opinion of the Investigator, could be harmful to the subject or compromise interpretation of the data - Iodine allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary sodium excretion 24h after a matched acute oral sodium load (in the absence or presence of GLP-1 receptor agonist) or an acute intravenous sodium load in T2DM patients with/without renal impairment, determined by the cumulative sodium balance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Variation in blood pressure, determined by non-invasive, automated, beat-to-beat blood pressure monitor (Nexfin®) measurements and 24h ABPM device, differences in total and fractional urinary sodium excretion and total sodium balance after 2, 4 and 6 hours, differences in plasma, urine and systemic hemodynamic markers, which include plasma hematocrit, hemoglobin, MCV, sodium, potassium, creatinine, urea, bicarbonate, chloride, glucose and GFR, urine creatinine, albumin, urea, osmolality, glucose, Na+, K+, Cl- (fractional and 24h collection), systemic hemodynamic; Cardiac output, peripheral vascular resistance, central blood pressure, heart rate and pulse wave velocity by application tonometry | — |
Countries
Netherlands
Outcome results
None listed